Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric a
FDA device recall Z-0332-2017 · posted 2016-11-02 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
- Action taken
- The firm sent the Urgent - Medical Device Correction letter, dated 18 October 2016, via priority service, return receipt requested, to all U.S. customers on 10/18/16. The firm will e-mail a customer letter (translated as necessary) to all international subsidiaries and distributors of record on October 25, 2016. Xhibit Central Stations used without Xhibit Telemetry Receivers, are not affected. Customers were asked to circulate the letter to all person affected and place a copy with the appropriate monitor user manual until corrections have been implemented. Spacelabs Healthcare will contact affected consignees to schedule a convenient time for Spacelabs to update the affected Xhibit Central Station(s) with a new software version 1.1.6 at no cost. Customers with questions can call Technical Support at 1-800-522-7025 and select 2.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 348 units (292 units in the US and 56 units outside the US)
- Distribution
- Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANAD
- Date initiated
- 2016-10-18
- Date posted
- 2016-11-02
- Date terminated
- 2017-04-03
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XHIBIT CENTRAL STATION, MODEL 96102 (K122146) | Spacelabs Healthcare | 2013-04-22 |