Recall Z-1198-2010 ยท HIF Insufflator, Laparoscopic
Stryker Endoscopy
Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.
| Date | Mar 23, 2010 (initiated Dec 29, 2008) |
| Status | Terminated |
| Reason | Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and interruption of ongoing surgical procedures. |
| Root cause | Component design/selection |
| Action | Recall initiated 12/29/2009. Sales representatives were notified via phone and e-mail, while product advisory notices were sent to consignees via FedEx. Consignees are provided with a response form, and are instructed to run a software correction. |
| Quantity | 884 devices |
| Distribution | Product was distributed throughout the US and to Argentina, Brazil, Canada, Chile and Latin America, as well as to 16 government facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 W.O.M. World of Medicine AG, May 23, 2007 |