Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-30
FDA device recall Z-0175-2010 · posted 2009-11-11 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."
- Action taken
- Consignees were notified by letter titled "Urgent Medical Device Recall-Immediate Action Required" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 173
- Distribution
- Nationwide.
- Date initiated
- 2009-09-17
- Date posted
- 2009-11-11
- Date terminated
- 2010-10-08
- Location
- Spencer, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445) | Electro Medical Systems SA | 2001-08-24 |