Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- January 27, 2004
- Posted
- July 20, 2004
- Terminated
- October 5, 2009
- Recall Number
- Z-1015-04
- Quantity
- 36
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
Distribution
Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.
Lot / Code Info
No serial numbers but the Dinalink protocol converter and cable has the product identifier of ''ILC1931''
Root Cause
Other
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.