Recall Z-0332-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
| Date | Nov 2, 2016 (initiated Oct 18, 2016) |
| Status | Terminated |
| Reason | The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally. |
| Root cause | Software design |
| Action | 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 cont |
| Quantity | 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, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 Spacelabs Healthcare, Apr 22, 2013 |