Z-0063-06

Tru-Link DIN unshielded ECG cable, 5-lead

Name: Z-0063-06 Tru-Link DIN unshielded ECG cable, 5-lead
Creator: Spacelabs Medical Incorporated
Published: 2005-09-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-09-16 / Terminated

FDA source

Spacelabs Medical Incorporated began a recall of Tru-Link DIN unshielded ECG cable, 5-lead on 2005-09-16. The reason FDA records is "ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0063-06
Status: Terminated
Initiated: 2005-09-16
Posted: 2005-11-03
Terminated: 2006-02-14
Recalling firm: GE Healthcare
Product: Tru-Link DIN unshielded ECG cable, 5-lead
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
FDA root cause: Other
Action: On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables.
Quantity in commerce: 632 cables
Distribution: Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
Product codes and lots: Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01

Product code DSI

K842616Class IISpacelabs Alpha Pc Patient ComputerSpacelabs, Inc. / cleared 1984-10-18

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)