Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol conv
FDA device recall Z-1015-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- Reason for recall
- The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
- Action taken
- The firm mailed an 'Urgent Medical Device Correction' letter to consignees on January 27, 2004 advising them of the external electrical noise problem and informing them to not use the Dinalink ILC1931 with patients with pace makers until a fix or replacement can be provided. By 5/17/2004 corrective replacement cables had been provided to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 36
- Distribution
- Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.
- Date initiated
- 2004-01-27
- Date posted
- 2004-07-20
- Date terminated
- 2009-10-05
- Location
- Tampa, FL
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