FDA Recall
Terminated
MD3 X-ray system
Recall: Z-0851-06
·
Initiated April 6, 2006
Recall
- Recall Number
- Z-0851-06
- Event Number
- 35177
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 6, 2006
- Posted
- May 6, 2006
- Terminated
- May 21, 2008
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
MD3 X-ray system
Reason
Potential for unexpected table movement.
Action
On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
Distribution
Units were distributed to hospitals and medical centers located throughou the US.
Quantity
37units