Recall Z-1806-2020 ยท KPR System, X-Ray, Stationary
Philips North America, LLC
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
| Date | Apr 7, 2020 |
| Status | Terminated |
| Reason | If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. |
| Root cause | Device Design |
| Action | Philips issued Urgent Field Safety Notice (FCO72000015) sent 4/09/20 via certified mail states reason for recall health risk, action to take: The IfU (Instruction for Use) require the operator to not use the system and call for service, if a mechanical defect or malfunction is suspected. As soon as a deformation is determined, the system may no longer be used and call the service engineer. Should you feel uncertain regarding these instructions, please contact Philips. If you would like any further information or support concerning this issue, please contact your local Philips representative. |
| Quantity | 346 units (5 US and 341 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom. |
| 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 |