Recall Z-2193-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis o
| Date | Aug 9, 2010 (initiated Jun 28, 2010) |
| Status | Terminated |
| Reason | RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch. |
| Root cause | Software design |
| Action | 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 import |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071859 | STRYKER CROSSFIRE SYSTEM Stryker Endoscopy, Sep 20, 2007 |