Recall archive / FDA device enforcement
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation ... — FDA record Z-1926-2024
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 May 2, 2024. 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
- Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
- Reason
- Potential for pressure wave data synchronization from two devices may not be correct.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 391 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1926-2024
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 | Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, 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(01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, 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(01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037, , (01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 4... |
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
Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.
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
- Jun 5, 2024
- Recall initiation date
- May 2, 2024
- Center classification date
- May 30, 2024
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.