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Terminated

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.

FDA Recall Z-1015-04 · Posted 2004-07-20

Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Product CodeMHX
Date Initiated2004-01-27
Date Terminated2009-10-05
Product Quantity36

Reason for Recall

The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.

Firm Action

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

Distribution Pattern

Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.

Official Source

View FDA Recall →

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

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