Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Cat
FDA device recall Z-0064-06 · posted 2005-10-19 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- The device has the potential for overheating its transformer and has the potential for fire hazard.
- Action taken
- The firm sent notification letters to its consignees on 2/18/05 and 5/18/05 via FedEx. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the PAM unit component.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRF
- Distribution
- Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sal
- Date initiated
- 2005-02-18
- Date posted
- 2005-10-19
- Date terminated
- 2006-01-30
- Location
- San Jose, CA
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