Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors.
FDA device recall Z-2211-2009 · posted 2009-09-11 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.
- Action taken
- Spacelabs Healthcare issued an "Urgent: Medical Device Recall" dated July 20, 2009. Consignees are being sent replacement ECG cables for each item ordered and are requested to replace the affected cables. Also, they are instructed to destroy and dispose of the recalled cables according to their own protocol or local regulations. For further information, contact Spacelabs Healthcare Technical Support at 1-800-522-7025, option 2 (US) or +86-512-87171888, extension 304 (outside US).
- Root cause
- Process control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 1,395
- Distribution
- International Distribution -- Bangladesh, Turkey, Trinidad and Tobago, Romania, Guatemala, Algeria, Netherlands, Egypt, Chile, Venezuela, Spain, Colombia, India, the United Kingdom, Singapore, France
- Date initiated
- 2009-07-23
- Date posted
- 2009-09-11
- Date terminated
- 2011-07-21
- Location
- Issaquah, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE (K090556) | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009-04-30 |