Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models ar
FDA device recall Z-2707-2014 · posted 2014-09-25 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- 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. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
- Action taken
- Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION (Expanded)" letter dated 5 September 2014 to all consignees in the US. This letter identified recalled model 91367, 91369, 91370, 91387, and 91393, Upgrade Kit 040-1548-00, Equipped with the Perioperative Option (-D), problem, and actions to be taken. On September 12, 2014, a recall notification letter (translated as necessary) will be 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 firm's Field Service Engineers will contact customers to schedule a time to come out to update affected monitors at no cost. Customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 82 units distributed in US and 140 units distributed outside US
- Distribution
- Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argent
- Date initiated
- 2014-08-26
- Date posted
- 2014-09-25
- Date terminated
- 2015-06-26
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL PATIENT MONITORS (K102422) | Spacelabs Medical, Inc. | 2010-12-07 |