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Class 2 Device Recall InfraVision IR Illuminator Console |
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Date Initiated by Firm |
September 29, 2010 |
Date Posted |
January 18, 2011 |
Recall Status1 |
Terminated 3 on February 09, 2011 |
Recall Number |
Z-0906-2011 |
Recall Event ID |
56871 |
510(K)Number |
K945297
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Product Classification |
Carrier, sponge, endoscopic - Product Code FGS
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Product |
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. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit. |
Code Information |
All lots and serial numbers are affected. |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138-1400
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For Additional Information Contact |
Michael Hilldoerfer 408-754-2664
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Manufacturer Reason for Recall |
Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.
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FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FGS and Original Applicant = GABRIEL MEDICAL, INC.
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