Recall Z-0906-2011 ยท FGS Carrier, Sponge, Endoscopic
Stryker Endoscopy
InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. i
| Date | Jan 18, 2011 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Stryker Endoscopy, sent an "Urgent: Device Correction" letter dated September 28, 2010, t o all consignees/customers via a Fed Ex Mailer that included notification letter, acknowledgment receipts and updated instructions for use. International Stryker sites received product advisory notification. Stryker reps at those sites are responsible for notifying customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to discard any old IFUs from the InfraVision Console and ensure that they only use InfraVision compatible s |
| Quantity | 861 units. |
| Distribution | Worldwide distribution: USA and countries including: Australia, Africa, Brazil, Canada, China, France, Greece, India, Italy, Korea, Latin America Mexico, New Zealand, Portugal, Romania, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945297 | INFRA VISION IMAGING SYSTEM Gabriel Medical, Inc., Dec 20, 1994 |