| Class 3 Device Recall Stryker Video Cart with Isolation Transformer |  |
Date Initiated by Firm | November 30, 2004 |
Date Posted | January 27, 2005 |
Recall Status1 |
Terminated 3 on May 13, 2005 |
Recall Number | Z-0417-05 |
Recall Event ID |
30763 |
510(K)Number | K935234 |
Product Classification |
Laparoscope, General & Plastic Surgery - Product Code GCJ
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Product | Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately. |
Code Information |
Model numbers 240-099-011- Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020. 240-099-012- serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. 240-099-020-serial numbers 040212001-032, 040309001-007, 040313001-010. 240-099-021-serial numbers 040224001-021, 040313017. 240-099-050-serial numbers 031218001-005, 031218031-045 |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138-1400
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Manufacturer Reason for Recall | A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices. |
FDA Determined Cause 2 | Device Design |
Action | The firm has initiated consignee notification by sending a notification letter and acknowledgement of receipt cards to its consignees. Service cards will be issued to firm sales representatives. |
Quantity in Commerce | 256 carts with transformers, 20 transformers |
Distribution | The products were distributed to 114 consignees. |
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 = GCJ
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