FDA Recall
Terminated
OmniDiagnost System
Recall: Z-0874-03
·
Initiated July 17, 2003
Recall
- Recall Number
- Z-0874-03
- Event Number
- 26837
- Firm
- Philips Medical Systems Sales & Service Region No. America
- FEI Number
- 1000524572
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 17, 2003
- Posted
- July 20, 2004
- Terminated
- January 12, 2005
- Address
- 22100 Bothell Everett Highway, Bothell, WA, 98041
Description
OmniDiagnost System
Reason
Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
Action
On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
Distribution
The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
Quantity
52