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Terminated

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.

FDA Recall Z-0417-05 · Posted 2005-01-27

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCJ
Date Initiated2004-11-30
Date Terminated2005-05-13
Product Quantity256 carts with transformers, 20 transformers

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

The products were distributed to 114 consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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