Atlas FDA

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer

FDA device recall Z-0417-05 · posted 2005-01-27 · Terminated

Recall details

Recalling firm
Stryker Endoscopy
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.
Action taken
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
Status
Terminated
Product code
GCJ
Quantity affected
256 carts with transformers, 20 transformers
Distribution
The products were distributed to 114 consignees.
Date initiated
2004-11-30
Date posted
2005-01-27
Date terminated
2005-05-13
Location
San Jose, CA

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Related 510(k) clearances

RecordFirmDate
STRYKER ENDOSCOPIC VIDEO ACCESSORIES (K935234)Stryker Endoscopy1994-03-18