Recall Z-2210-2010 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
| Date | Aug 11, 2010 (initiated Jun 26, 2008) |
| Status | Terminated |
| Reason | Monitor ceiling carriage may separate from the monitor ceiling suspension. |
| Root cause | Other |
| Action | On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technician |
| Quantity | 1111 units |
| Distribution | United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.