FDA Device

Tru-Link DIN unshielded ECG cable, 5-lead

Hazard

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

What You Should Do

Remedy

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.

Products

Tru-Link DIN unshielded ECG cable, 5-lead
Brand
Spacelabs Medical Incorporated
UPC
Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01

Units Affected

632 cables