FDA Medical Device Recalls (openFDA)
Spacelabs Medical Incorporated: Tru-Link DIN unshielded ECG cable, 5-lead
- Recall number
- Z-0063-06
- Recalling firm
- Spacelabs Medical Incorporated
- Product
- Tru-Link DIN unshielded ECG cable, 5-lead
- Status
- Terminated
- Initiated
- 2005-09-16
- Posted
- 2005-11-03
- Terminated
- 2006-02-14
- Reason
- ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
- 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
- 632 cables
- Distribution
- Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
- Lot, serial or model codes
- Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
- 510(k) numbers
- ["K842616"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28