Recall Z-1383-2023 ยท KPR System, X-Ray, Stationary
Philips North America Llc
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
| Date | Apr 12, 2023 (initiated Mar 9, 2023) |
| Status | Open, Classified |
| Reason | If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users |
| Root cause | Equipment maintenance |
| Action | Philips issued Urgent Medical Device Correction Letter to US Consignees on 09-Mar-2023. Letter states reason for recall, health risk and action to take: Follow the Planned Maintenance Program in the Addendum to the Instructions for Use in Appendix A of this notice for the safe use of your system(s). " If the Ceiling Suspension is not able to be kept in its current position by itself and descends after the power to the system is off, contact your local Philips representative to perform the maintenance of the telescopic carriage. " Place this URGENT Medical Device Correction Notice with the doc |
| Quantity | 10 units US; 283 units OUS |
| Distribution | Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zeal |
| FDA record | Open on fda.gov |