Tru-Link DIN unshielded ECG cable, 5-lead
FDA device recall Z-0063-06 · posted 2005-11-03 · Terminated
Recall details
- Recalling firm
- Spacelabs Medical Incorporated
- Reason for recall
- ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
- Action taken
- 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
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 632 cables
- Distribution
- Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
- Date initiated
- 2005-09-16
- Date posted
- 2005-11-03
- Date terminated
- 2006-02-14
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS ALPHA PC PATIENT COMPUTER (K842616) | Spacelabs, Inc. | 1984-10-18 |