Recall Z-0059-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)
| Date | Nov 10, 2007 (initiated Aug 23, 2007) |
| Status | Terminated |
| Reason | System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control. |
| Root cause | Software design |
| Action | On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem. |
| Quantity | 596 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.