Recall Z-0175-2010 ยท FFK Lithotriptor, Electro-Hydraulic
Boston Scientific Corp
Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Nati
| Date | Nov 11, 2009 (initiated Sep 17, 2009) |
| Status | Terminated |
| Reason | 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." |
| Root cause | Other |
| Action | 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. |
| Quantity | 173 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA, Aug 24, 2001 |