FDA Medical Device Recalls (openFDA)
Del Mar Reynolds Medical, Ltd.: SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
- Recall number
- Z-1442-2014
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Product
- SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
- Status
- Terminated
- Initiated
- 2014-03-10
- Posted
- 2014-04-12
- Terminated
- 2014-08-20
- Reason
- The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
- Root cause
- Software in the Use Environment
- Action
- 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.
- Quantity
- 16 units distributed in the US
- Distribution
- USA Nationwide Distribution in the states of North Carolina and South Carolina
- Lot, serial or model codes
- SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
- 510(k) numbers
- ["K113051"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002807992
- Firm city
- Hertford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28