Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelab
FDA device recall Z-0072-2018 · posted 2017-11-21 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Reason for recall
- Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
- Action taken
- Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.
- Root cause
- Software design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 110 units
- Distribution
- Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
- Date initiated
- 2017-10-11
- Date posted
- 2017-11-21
- Date terminated
- 2018-03-12
- 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 |