qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches
FDA device recall Z-0403-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.
- Action taken
- Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated October 19, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact Spacelabs Healthcare at 1-800522-7025 option 2 for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 742 total devices distributed; 530 with the U.S. and 212 Internationally.
- Distribution
- Worldwide Distribution.On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913. The two additional serial numbers were added because they were provided as replacement
- Date initiated
- 2012-10-19
- Date posted
- 2012-11-20
- Date terminated
- 2013-05-22
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (K120616) | Spacelabs Medical, Inc. | 2012-03-29 |