| Date Initiated by Firm | March 14, 2005 |
|---|
| Date Posted | November 01, 2005 |
|---|
| Recall Status1 |
Terminated 3 on December 13, 2005 |
| Recall Number | Z-0112-06 |
|---|
| Recall Event ID |
33446 |
| 510(K)Number | K992912 |
|---|
| Product Classification |
Computer, Diagnostic, Programmable - Product Code DQK
|
| Product | Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300 |
|---|
| Code Information |
All lots |
| FEI Number |
3001236349
|
Recalling Firm/
Manufacturer |
Boston Scientific
2710 Orchard Pkwy
San Jose CA 95134-2012
|
| For Additional Information Contact | Pierre A. Boisier
408-895-3670 |
|---|
Manufacturer Reason
for Recall | The device has the potential for overheating its transformer and has the potential for fire hazard. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm sent notification letters to its consignees on April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit. |
|---|
| Quantity in Commerce | 69 units distributed worldwide |
|---|
| Distribution | 32 units have been distributed throughout the US, and 37 units distributed internationally. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = DQK
|
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