Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.
FDA device recall Z-1198-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HIF
- Quantity affected
- 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.
- Date initiated
- 2008-12-29
- Date posted
- 2010-03-23
- Date terminated
- 2011-03-24
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 45L CORE INSUFFLATOR, MODEL F114 (K063367) | W.O.M. World of Medicine AG | 2007-05-23 |