MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilit
FDA device recall Z-0586-2016 · posted 2016-01-11 · Terminated
Recall details
- Recalling firm
- Thornhill Research Inc
- Reason for recall
- Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
- Action taken
- Thornhill Research sent a Recall Notification letter dated December 15, 2015 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to update their device software. For questions customers were instructed to call 416-597-1325.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 83 units
- Distribution
- Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
- Date initiated
- 2015-11-19
- Date posted
- 2016-01-11
- Date terminated
- 2019-04-12
- Location
- Toronto, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOVES (K093261) | Thornhill Research, Inc. | 2010-03-26 |