Spacelabs Medical Incorporated Tru-Link DIN unshielded ECG cable, 5-lead Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tru-Link DIN unshielded ECG cable, 5-lead
Brand
Spacelabs Medical Incorporated
Lot Codes / Batch Numbers
Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
Products Sold
Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
Spacelabs Medical Incorporated is recalling Tru-Link DIN unshielded ECG cable, 5-lead due to ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026