Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models ar
FDA device recall Z-3032-2011 · posted 2011-08-17 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.
- Action taken
- Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated July 25, 2011 along with the Perioperative section of the Operations Manual to all consignees in the US. This letter includes recalled model 91369, 91370, 91387, & 91393 (option D). On July 27, 2011, Spacelabs sent out an updated recall notification letter to include one additional model 91367 to all consignees in the US. The letter identifies the products, problem, and actions to be taken. On August 2, 2011, a recall notification letter (translated as necessary) and the Perioperative section of the Operations Manual was emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The letter states that the firm is in the process of upgrading the software and will be contacting customers to update monitors at no cost. If customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- total 2812 units distributed worldwide
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, Bahrain, Bolivia, Brazil, Canada, Caymen Island, Chile, China, Colombia, Cyprus, Ecuador, Finland, France, Germany
- Date initiated
- 2011-07-08
- Date posted
- 2011-08-17
- Date terminated
- 2012-05-23
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL PATIENT MONITORS (K102422) | Spacelabs Medical, Inc. | 2010-12-07 |