SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
FDA device recall Z-1442-2014 · posted 2014-04-12 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Reason for recall
- The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
- Action taken
- Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 16 units distributed in the US
- Distribution
- USA Nationwide Distribution in the states of North Carolina and South Carolina
- Date initiated
- 2014-03-10
- Date posted
- 2014-04-12
- Date terminated
- 2014-08-20
- Location
- Hertford, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS ARKON ANESTHESIA WORKSTATION (K113051) | Spacelabs Healthcare | 2012-03-22 |