Recall Z-0273-2024
Philips North America Llc · initiated September 21, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Codes / lots: Model No. 712028, 712227, & 712032; UDI: (01)00884838074514(21)SN18000410, (01)00884838074514(21)SN18000253, (01)00884838074514(21)SN18000339, (01)00884838074514(21)SN18000332, (01)00884838074514(21)SN18000448, (01)00884838074514(21)SN18000306, (01)00884838074514(21)SN18000397, (01)00884838074514(21)SN18000366, (01)00884838074514(21)SN18000391, (01)00884838074514(21)SN18000431, (01)00884838074514(21)SN19000191, (01)00884838074514(21)SN19000119, (01)00884838074514(21)SN19000217, (01)00884838074514(21)SN19000109, (01)00884838074514(21)SN19000260, (01)00884838074514(21)SN20000159, (01)00884838074514(21)SN19000328, (01)00884838074514(21)SN20000372, (01)00884838074514(21)SN20000277, (01)00884838074514(21)SN20000003, (01)00884838074514(21)SN20000052, (01)00884838074514(21)SN19000321, (01)00884838074514(21)SN20000039, (01)00884838074514(21)SN20000121, (01)00884838074514(21)SN18000024 , (01)00884838074514(21) SN15000304 , (01)00884838074514(21) SN15000283 , (01)00884838074514(21) SN15000252 , (01)00884838074514(21) SN15000255 , (01)00884838074514(21) SN18000274 , (01)00884838074514(21) SN16000009 , (01)00884838074514(21) SN16000036 , (01)00884838074514(21) SN16000262…
Reason for recall
Potential for units suspended on the ceiling to fail and fall.
FDA-determined cause: Under Investigation by firm
Action taken
The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to pd.cnr@philips.com. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.
Details
- Recall number
- Z-0273-2024
- Initiated
- September 21, 2023
- Posted by FDA
- November 8, 2023
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 92 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0271-2024 Class II | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) systemPotential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0272-2024 Class II | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0274-2024 Class II | DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0275-2024 Class II | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0276-2024 Class II | DigitalDiagnost C90 High Performance, used to acquire, process, store, display and…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0277-2024 Class II | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0278-2024 Class II | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0279-2024 Class II | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |
| Z-0280-2024 Class II | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) systemPotential for units suspended on the ceiling to fail and fall. | 09/21/2023Open, Classified |