Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to
FDA device recall Z-2886-2016 · posted 2016-09-26 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
- Action taken
- Spacelabs sent a letter dated August 25, 2016 to affected US consignees informing them of the going offline or locking up issue when Xhibit Central Station is used as part of an Xhibit Telemetry System. On September 1, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs sent the second Urgent - Medical Device Correction letter, dated September 15, 2016, to affected US consignees informing them that they have received reports of certain short-duration asystole alarms generated by the Xhibit Telemetry Receiver (XTR) where there may be no audible or visual alarm. On September 22, 2016, a second letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to update the recalled Xhibit Telemetry System at no cost. Customers with Xhibit Telemetry Receivers will get all Xhibit Central Stations updated regardless if connected to an Xhibit Telemetry Receiver. Consignees are directed to technical support for additional information or technical assistance: Technical Support Spacelabs Healthcare, Inc 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 316 XTR units total (248 units in the US and 68 units outside US)
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
- Date initiated
- 2016-08-25
- Date posted
- 2016-09-26
- Date terminated
- 2017-03-13
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS HEALTHCARE TELEMETRY RECEIVER (K141156) | Spacelabs Healthcare | 2014-09-09 |