Recall Z-0303-2008 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Communications
Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)
| Date | Jan 12, 2008 (initiated Oct 3, 2007) |
| Status | Terminated |
| Reason | Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery. |
| Root cause | Nonconforming Material/Component |
| Action | Firm notified consignees of recall via letter (Urgent Device Recall) on 09/21/07. Consignees were notified that a customer service representative would visit each facility to replace out-of-spec cables with properly shielded cables at no charge. |
| Quantity | 1,653 cables. |
| Distribution | Worldwide: USA and Australia, Belgium, Canada, France, Germany, Great Britain, Hong Kong, Japan, Korea, Mexico, Netherlands, New Zealand, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, and The U.A.E. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033132 | STRYKER SWITCHPOINT INFINITY Stryker Communications Corp., Sep 2, 2004 |