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.
Recall
- Recall Number
- Z-2210-2010
- Event Number
- 48992
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 26, 2008
- Posted
- August 11, 2010
- Terminated
- December 2, 2010
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
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.
Monitor ceiling carriage may separate from the monitor ceiling suspension.
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 technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.
United States and Canada.
1111 units