Recall Z-0766-2016 ยท KPR System, X-Ray, Stationary
Philips Electronics North America Corporation
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
| Date | Jul 22, 2015 |
| Status | Terminated |
| Reason | If arm is not fastened securely it could fall down. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implem |
| Quantity | 399 distributed, 262 are subject to this event |
| Distribution | Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945278 | PHILIPS BUCKY DIAGNOST FAMILY Philips Medical Systems North America, Inc., Dec 14, 1994 |