InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with t
FDA device recall Z-0906-2011 · posted 2011-01-18 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.
- Action taken
- 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 scopes; read the newly updated IFU provided with the letter; and complete and sign the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in or email to infravision@stryker.com. Note: Not returning the "acknowledgement of receipt" card will result in additional notices. Please contact your local Stryker sales representative to obtain information on scopes that are specific to the InfraVision system. If you have any questions, please contact us at 1-800-624-4422 or email at infravision@stryker.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FGS
- Quantity affected
- 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, Swe
- Date initiated
- 2010-09-29
- Date posted
- 2011-01-18
- Date terminated
- 2011-02-09
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFRA VISION IMAGING SYSTEM (K945297) | Gabriel Medical, Inc. | 1994-12-20 |