Z-1015-04

Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated...

Name: Z-1015-04 Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated...
Creator: GE Medical Systems Information Technologies
Published: 2004-01-27
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2004-01-27 / Terminated

FDA source

GE Medical Systems Information Technologies began a recall of 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... on 2004-01-27. The reason FDA records is "The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1015-04
Status: Terminated
Initiated: 2004-01-27
Posted: 2004-07-20
Terminated: 2009-10-05
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
FDA root cause: Other
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.
Quantity in commerce: 36
Distribution: Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.
Product codes and lots: No serial numbers but the Dinalink protocol converter and cable has the product identifier of ''ILC1931''

Product code MHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)