Recall Z-1803-2010 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Communications Corp
The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room. The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE) are designed as an integrated voice, video, data router and teleconferencing interface for the operating room. The primary intent of the SPI2 and SPE product lines is to allow
| Date | Jun 15, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel. |
| Root cause | Component design/selection |
| Action | The firm, Stryker, sent an "URGENT: Medical Device Correction" letter dated May 4, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The firm recommended that the customer continue to use their SwitchPoint Infinity 2 or SwitchPoint Element. The customer is instructed to refer to their user manual, in the event they experience any failures; drive on module failure and/or product failure during a procedure. A Stryker representative will contact the customers facility to coordinate a service event to replace the existing component wit |
| Quantity | 1,118 devices |
| Distribution | Worldwide distribution: USA and countries of Australia, EMEA, Canada, China, S. Africa, India, Japan, Latin America, Korea, Mexico, New Zealand, Taiwan, and Signapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033132 | STRYKER SWITCHPOINT INFINITY Stryker Communications Corp., Sep 2, 2004 |