Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device indicated for use
FDA device recall Z-2193-2010 · posted 2010-08-09 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
- Action taken
- Stryker Endoscopy sent an "Urgent: Device Correction" letter dated June 28, 2010, via FedEX Mailer to US customers. A letter dated July 9, 2010, was sent to International sites.The letter describes the product, problem, and action to be taken by customers. The Customers were instructed to follow the included instructions and use the USB dongle to install the correction and to complete and sign the enclosed "acknowledgement of receipt" form,upon completion of the software correction, and fax to (480) 754-8378 or scan in and email to crossfireconsole@stryker.com. The firm noted that-It is important to send the self addressed confirmation forms back to Stryker RAQA. If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at crossfireconsole@stryker.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 989 units
- Distribution
- Worldwide distribution: USA and countries including Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EMEA.
- Date initiated
- 2010-06-28
- Date posted
- 2010-08-09
- Date terminated
- 2011-03-21
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER CROSSFIRE SYSTEM (K071859) | Stryker Endoscopy | 2007-09-20 |