Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central S
FDA device recall Z-3024-2011 · posted 2011-08-15 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.
- Action taken
- Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken. The letter includes the revised Operator's Manual as a replacement for customers current manual. For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 2517
- Distribution
- Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUB
- Date initiated
- 2010-09-23
- Date posted
- 2011-08-15
- Date terminated
- 2011-08-17
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (K093501) | Spacelabs Medical, Inc. | 2009-11-24 |