Recall archive / FDA device enforcement
X8-2t Transducer Probe — FDA record Z-2413-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- X8-2t Transducer Probe
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Classification
- Class III
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 171,322 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2413-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718(21)B2XD88, (01)00884838069718(21)B3DRBX, (01)00884838069718(21)B3DRF0, (01)00884838069718(21)B3DRGX, (01)00884838069718(21)F0GWCW, (01)00884838069718(21)B277WX, (01)00884838069718(21)F04WX2, (01)00884838069718(21)F0B4PV, (01)00884838069718(21)B2VQJ5, (01)00884838069718(21)F010V3, (01)00884838069718(21)F042C2, (01)00884838069718(21)F06TQ3, (01)00884838069718(21)F086C1, (01)00884838069718(21)F086C2, (01)00884838069718(21)F08835, (01)00884838069718(21)F09BV3, (01)00884838069718(21)F0DK0W, (01)00884838069718(21)F0FDNF, (01)00884838069718(21)F0K1TQ, (01)00884838069718(21)F0K5JZ, (01)00884838069718(21)F0186H, (01)00884838069718(21)F03RVN, (01)00884838069718(21)F052P3, (01)00884838069718(21)F05445, (01)00884838069718(21)F0BRLQ, (01)00884838069718(21)F0D1XZ, (01)00884838069718(21)B2JHG3, (01)00884838069718(21)B39B92, (01)00884838069718(21)F0LW0Y, (01)00884838069718(21)F0LW10, (01)00884838069718(21)F02ZG0, (01)00884838069718(21)B3DRL7, (01)00884838069718(21)F016MN, (01)00884838069718(21)F02R78, (01)00884838069718(21)F04C9H, (01)00884838069718(21)F04ZB0, (01)00884838069718(21)F0640W, (01)00884838069718(21)F09JV7, (01)00884838069718(21)F0CPG5, (01)00884838069718(21)F0CY3N, (01)00884838069718(21)F0DT5W, (01)00884838069718(21)F0F1QM, (01)00884838069718(21)F0FLG7, (01)00884838069718(21)F0FRL7, (01)00884838069718(21)F0GMVF, (01)00884838069718(21)F0GR8T, (01)00884838069718(21)F0GRGV, (01)00884838069718(21)F0GTBQ, (01)00884838069718(21)F0GTC0, (01)00884838069718(21)F0GVL6, (01)00884838069718(21)F0GWYQ, (01)00884838069718(21)F0GZBN, (01)00884838069718(21)F0LHWM, (01)00884838069718(21)B2VQBH, (01)00884838069718(21)F055VW, (01)00884838069718(21)F0BJ8J, (01)00884838069718(21)F0D02W, 010088483806971821F0GHKX, (01)00884838069718(21)F02MYD, (01)00884838069718(21)F02GFC, (01)00884838069718(21)F04XZ4, (01)00884838069718(21)F0F1Q1, (01)00884838069718(21)F0F4DL, (01)00884838069718(21)F0FPZR, (01)00884838069718(21)F0FQ06, (01)00884838069718(21)F0GJKN, (01)00884838069718(21)B3PG6B, (01)00884838069718(21)F05GR9, (01)00884838069718(21)F07KQX, (01)00884838069718(21)F0BTBB, (01)00884838069718(21)F0CWL9, (01)00884838069718(21)F0HJWV, (01)00884838069718(21)F0HLZW, (01)00884838069718(21)F0HM6X, (01)00884838069718(21)B29MKB, (01)00884838069718(21)B2XDFN, (01)00884838069718(21)B38VN3, (01)00884838069718(21)F0LW16, (01)00884838069718(21)F0LV4B, (01)00884838069718(21)B24WTK, (01)00884838069718(21)B3DRVC, (01)00884838069718(21)B3J4JP, (01)00884838069718(21)B3PG0B, (01)00884838069718(21)F006T8, (01)00884838069718(21)F03G19, (01)00884838069718(21)F03N6G, (01)00884838069718(21)F058PF, (01)00884838069718(21)F0BBD7, (01)00884838069718(21)F0C4C9, (01)00884838069718(21)F0DFYG, (01)00884838069718(21)F0DR83, (01)00884838069718(21)F0K5N9, (01)00884838069718(21)F0LL9R, 010088483806971821B3VH5Z, (01)00884838069718(21)B34TH6, (01)00884838069718(21)F02227, (01)00884838069718(21)F02G0V, (01)00884838069718(21)F02YRK, (01)00884838069718(21)F0CYCC, (01)00884838069718(21)F0CZ83, 010088483806971821F029L0, 010088483806971821F0GBL8, 010088483806971821F0GFTT, (01)00884838069718(21)B3PFVV, (01)00884838069718(21)F02R62, (01)00884838069718(21)F03K7H, (01)00884838069718(21)F039W0, (01)00884838069718(21)F04H3Y, (01)00884838069718(21)F052PH, (01)00884838069718(21)F067B6, (01)00884838069718(21)F0HDLJ, (01)00884838069718(21)B2F0R4, (01)00884838069718(21)B2JH9H, (01)00884838069718(21)B2NMFG, (01)00884838069718(21)B2VQLJ, (01)00884838069718(21)B2VQVY, (01)00884838069718(21)B34TTC, (01)00884838069718(21)B3J472, (01)00884838069718(21)B3J475, (01)00884838069718(21)B3J47Z, (01)00884838069718(21)F02JDV, (01)00884838069718(21)F049HT, (01)00884838069718(21)F052Y6, (01)00884838069718(21)F0FJ9K, (01)00884838069718(21)F0JYH0, (01)00884838069718(21)F0KCV1, (01)00884838069718(21)F0KJN9, (01)00884838069718(21)B2B4YK, (01)00884838069718(21)B3VFRT, (01)00884838069718(21)F058PN, (01)00884838069718(21)F0HM78, (01)00884838069718(21)F0KH16, (01)00884838069718(21)F0KYPJ, (01)00884838069718(21)B2JGRJ, (01)00884838069718(21)B2VQWN, (01)00884838069718(21)B3MWT2, (01)00884838069718(21)F02YZP, (01)00884838069718(21)F04JMT, 010088483806971821F0G8GC, (01)00884838069718(21)F0LTQN, (01)00884838069718(21)B3RDGJ, (01)00884838069718(21)B23F75, (01)00884838069718(21)B23FBG, (01)00884838069718(21)B24DW0, (01)00884838069718(21)F0C7L3, (01)00884838069718(21)F0C93N, (01)00884838069718(21)F0CC13, (01)00884838069718(21)B2JGND, (01)00884838069718(21)B2T8D6, (01)00884838069718(21)F02TWX, (01)00884838069718(21)F0DFY6, (01)00884838069718(21)F0DR76, (01)00884838069718(21)B24VJZ, (01)00884838069718(21)B24W1C, (01)00884838069718(21)B2BNB5, (01)00884838069718(21)B2GD2V, (01)00884838069718(21)B2JGL7, (01)00884838069718(21)B2VQJ7, (01)00884838069718(21)B2VQMW, (01)00884838069718(21)B2VQNT, (01)00884838069718(21)F046GD, (01)00884838069718(21)F046GR, (01)00884838069718(21)F0DHPV, (01)00884838069718(21)F0DK0L, (01)00884838069718(21)F0DK15, (01)00884838069718(21)F0DK17, (01)00884838069718(21)F0DK19, (01)00884838069718(21)F0DM13, (01)00884838069718(21)F0L9Z4, 010088483806971821F01HPQ, (01)00884838069718(21)F0HHNY, (01)00884838069718(21)F0KDD7, (01)00884838069718(21)F07XC0, (01)00884838069718(21)F0DRP2, (01)00884838069718(21)F0B3XM, (01)00884838069718(21)F04DK9, (01)00884838069718(21)F01GW2, (01)00884838069718(21)F0H6H3, (01)00884838069718(21)F0FM8H, (01)00884838069718(21)B292B2, (01)00884838069718(21)B29MQZ, (01)00884838069718(21)B2JJQ5, (01)00884838069718(21)B3DRR0, (01)00884838069718(21)B3M1K2, (01)00884838069718(21)F066VP, 010088483806971821F0GC26, (01)00884838069718(21)B2JH8T, (01)00884838069718(21)B2JJB7, (01)00884838069718(21)F02GDK, (01)00884838069718(21)F02YT1, (01)00884838069718(21)F03K7J, (01)00884838069718(21)F049HP, (01)00884838069718(21)F055VF, (01)00884838069718(21)F09CNM, 010088483806971821F0294X, (01)00884838069718(21)F06LLV, (01)00884838069718(21)F09HYM, (01)00884838069718(21)F0DD7M, (01)00884838069718(21)F0HDL5, 010088483806971821F0FYP1, 010088483806971821F0FZZD, 010088483806971821F0G0D9, 010088483806971821F0G0DP, (01)00884838069718(21)B29LVP, (01)00884838069718(21)B2D4C6, (01)00884838069718(21)B2JHNJ, (01)00884838069718(21)B3DRYM, (01)00884838069718(21)B3DRZ4, (01)00884838069718(21)B3DT34, (01)00884838069718(21)B3DT5N, (01)00884838069718(21)B3DT8G, (01)00884838069718(21)B3DT9F, (01)00884838069718(21)B3J450, (01)00884838069718(21)B3PG5Y, (01)00884838069718(21)F05LYX, (01)00884838069718(21)F05XQY, (01)00884838069718(21)F05YFR, 010088483806971821F0H2NC, (01)00884838069718(21)B20TFR, (01)00884838069718(21)B2JGV2, (01)00884838069718(21)B34Z2P, (01)00884838069718(21)F02JFC, (01)00884838069718(21)F02JFL, (01)00884838069718(21)F0H249, (01)00884838069718(21)B2FF0G, (01)00884838069718(21)B38VJL, (01)00884838069718(21)B38VNB, (01)00884838069718(21)B3DT8H, (01)00884838069718(21)B3J4BJ, (01)00884838069718(21)B3J4KK, (01)00884838069718(21)B3MWV8, (01)00884838069718(21)B3PG1J, (01)00884838069718(21)F00XWP, (01)00884838069718(21)F04GGM, (01)00884838069718(21)F05449, (01)00884838069718(21)F05QTN, (01)00884838069718(21)F05WZV, (01)00884838069718(21)F05YG1, (01)00884838069718(21)F05Z54, (01)00884838069718(21)B39BGZ, (01)00884838069718(21)F01F20, (01)00884838069718(21)F01F9Y, (01)00884838069718(21)F0B8DM, 010088483806971821F023TF, 010088483806971821F027CD, (01)00884838069718(21)F0LTR5, (01)00884838069718(21)B2G9B4, (01)00884838069718(21)F01HM1, (01)00884838069718(21)F02W2X, (01)00884838069718(21)F08XL1, (01)00884838069718(21)F0C425, (01)00884838069718(21)F06XZ9, (01)00884838069718(21)F0DB8R, (01)00884838069718(21)F0DTPG, (01)00884838069718(21)F0GZXG, (01)00884838069718(21)F0H1HH, (01)00884838069718(21)F04H2X, (01)00884838069718(21)F0KJN5, (01)00884838069718(21)F0H11K, (01)00884838069718(21)F00XWQ, (01)00884838069718(21)F02X0M, (01)00884838069718(21)F033ZD, (01)00884838069718(21)F04KM6, (01)00884838069718(21)F0543J, (01)00884838069718(21)F0GRGW, (01)00884838069718(21)F0HBYT, (01)00884838069718(21)F0HCM0, (01)00884838069718(21)F0JL4Z, (01)00884838069718(21)F0JYHC, (01)00884838069718(21)B1VX7M, (01)00884838069718(21)B29MPY, (01)00884838069718(21)B2CHKC, (01)00884838069718(21)B2FD4L, (01)00884838069718(21)B2JGV7, (01)00884838069718(21)B2JJBX, (01)00884838069718(21)B3DRTH, (01)00884838069718(21)B3PFR9, (01)00884838069718(21)F02P24, (01)00884838069718(21)F03Q08, (01)00884838069718(21)F07FXN, (01)00884838069718(21)F082H2, (01)00884838069718(21)F086BW, (01)00884838069718(21)F08Q8N, (01)00884838069718(21)F0CF2V, (01)00884838069718(21)F0DMLZ, (01)00884838069718(21)F0DQCD, (01)00884838069718(21)F0K527, (01)00884838069718(21)F0K6HP, (01)00884838069718(21)F0K6HT, (01)00884838069718(21)F0CG3M, (01)00884838069718(21)B24VZG, (01)00884838069718(21)B2BN6M, (01)00884838069718(21)B2VQFG, (01)00884838069718(21)F063J2, (01)00884838069718(21)F02D5D, (01)00884838069718(21)F06KL3, (01)00884838069718(21)B26K07, (01)00884838069718(21)B38VH4, (01)00884838069718(21)B3J4FR, (01)00884838069718(21)B3J4G2, (01)00884838069718(21)B3M1L5, (01)00884838069718(21)F0D63N, (01)00884838069718(21)F0D64B, (01)00884838069718(21)F0D7MF, (01)00884838069718(21)F0FG3K, (01)00884838069718(21)F0KRQ8, (01)00884838069718(21)F0KRQN, (01)00884838069718(21)B26LDD, (01)00884838069718(21)B26MYW, (01)00884838069718(21)F09WZN, (01)00884838069718(21)F09Y15, (01)00884838069718(21)F0B1G4, (01)00884838069718(21)F0B3YJ, (01)00884838069718(21)F0B3YL, (01)00884838069718(21)F01RFF, (01)00884838069718(21)F052ZF, (01)00884838069718(21)F08LGG, (01)00884838069718(21)F08QLM, (01)00884838069718(21)F0K712, (01)00884838069718(21)F040NJ, (01)00884838069718(21)F0CV98, (01)00884838069718(21)F0DFY0, (01)00884838069718(21)F0DR78, (01)00884838069718(21)F0DT61, (01)00884838069718(21)F0DTPQ, (01)00884838069718(21)F042GD, (01)00884838069718(21)F073WK, (01)00884838069718(21)F08FYG, (01)00884838069718(21)F0D37K, (01)00884838069718(21)F0DMKG, (01)00884838069718(21)B3RR62, (01)00884838069718(21)F0LG63, (01)00884838069718(21)B2XD6P, (01)00884838069718(21)F0BFHD, (01)00884838069718(21)F0CWLN, (01)00884838069718(21)F01HQ9, (01)00884838069718(21)F04KMC, (01)00884838069718(21)F0FPXM, (01)00884838069718(21)F0GNKB, 010088483806971821F0GNWJ, (01)00884838069718(21)B2XCYR, (01)00884838069718(21)F0BKR2, (01)00884838069718(21)F0JMQ9, (01)00884838069718(21)F0K3GG, (01)00884838069718(21)B2JH6L, (01)00884838069718(21)B3PFZ5, (01)00884838069718(21)F03KKK, (01)00884838069718(21)F0KVGX, 010088483806971821F020K1, (01)00884838069718(21)F00VZV, (01)00884838069718(21)F00ZCG, (01)00884838069718(21)F052Q7, (01)00884838069718(21)F05C9Y, (01)00884838069718(21)F0BRKV, (01)00884838069718(21)F0BRLL, (01)00884838069718(21)B3DT93, (01)00884838069718(21)F04381, (01)00884838069718(21)F04H2Z, (01)00884838069718(21)F0B4PL, (01)00884838069718(21)F0FPXB, (01)00884838069718(21)F0FW1W, (01)00884838069718(21)F0GR91, 010088483806971821F00PRN, (01)00884838069718(21)B2D3GV, (01)00884838069718(21)B38VMM, (01)00884838069718(21)B3J4HD, (01)00884838069718(21)B3J4HK, (01)00884838069718(21)B3J4KF, (01)00884838069718(21)F00RM2, (01)00884838069718(21)F031JT, (01)00884838069718(21)F07QYY, (01)00884838069718(21)F09JV3, (01)00884838069718(21)F09JVL, (01)00884838069718(21)F0CYBT, (01)00884838069718(21)F0JBT3, (01)00884838069718(21)F089FX, (01)00884838069718(21)F0FG39, (01)00884838069718(21)F0HKHM, (01)00884838069718(21)B2XDJH, (01)00884838069718(21)B34TQH, (01)00884838069718(21)B1ZJ8R, (01)00884838069718(21)B277WY, (01)00884838069718(21)F01810, (01)00884838069718(21)F02WZJ, (01)00884838069718(21)F02X0D, (01)00884838069718(21)F02Y5X, (01)00884838069718(21)F02YRV, (01)00884838069718(21)F02YTQ, (01)00884838069718(21)F02YZF, (01)00884838069718(21)F064QP, (01)00884838069718(21)F065QT, (01)00884838069718(21)F09LC6, (01)00884838069718(21)F09LCN, (01)00884838069718(21)F09R5X, (01)00884838069718(21)F09V01, (01)00884838069718(21)F0FBN2, (01)00884838069718(21)B2FBZK, (01)00884838069718(21)B2JJDN, (01)00884838069718(21)B2VQ5M, (0... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 3, 2025
- Center classification date
- Aug 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.