Recall archive / FDA device enforcement
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 — FDA record Z-1585-2023
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 Mar 20, 2023. 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 Incisive CT -Computed Tomography X-Ray System Model Number: 72814
- Reason
- Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
- Classification
- Class II
- Recalling firm
- Philips North America
- Quantity
- 10 units US; 36 units OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1585-2023
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 | UDI-DI: (01)00884838105508(21) + Serial number US Serial Numbers: 550243, 34111, 34092, 34066, 34064, 34047, 34042, 34025, 34031, 34033 OUS Serial Numbers: System Serial Number 550263 550249 550239 550215 550211 550091 550188 550187 550186 550174 550172 552041 550164 34107 550140 34062 550099 550082 550071 550068 550059 34020 550038 550040 550021 550036 550018 550014 550011 550010 550009 550008 550007 550240 550126 550241 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, Republic Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten (Dutch part), South Africa, Thailand, United Kingdom, Utd. Arab. Emir.
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
- May 24, 2023
- Recall initiation date
- Mar 20, 2023
- Center classification date
- May 12, 2023
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.