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Terminated

Tru-Link DIN unshielded ECG cable, 5-lead

FDA Recall Z-0063-06 · Posted 2005-11-03

Recalling FirmSpacelabs Medical Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2005-09-16
Date Terminated2006-02-14
Product Quantity632 cables

Reason for Recall

ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.

Firm 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.

Root Cause

Other

Distribution Pattern

Cables were distributed to 9 US hospitals/medical centers and 30 international customers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842616SPACELABS ALPHA PC PATIENT COMPUTERSpacelabs, Inc. · 1984-10-18

Official Source

View FDA Recall →

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

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