Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Mode
FDA device recall Z-2589-2018 · posted 2018-08-10 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Reason for recall
- Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
- Action taken
- The firm, Spacelabs Healthcare, sent "Field Corrective Action Display Unit Resets" letters dated 7/3/2018 and 7/9/2018 to its customers via priority service on 07/11/2018. The letters informed them to circulate this notification to all affected persons and to add copies to appropriate user manuals. The firm will contact customers to replace the display assembly.. Customers with questions are encouraged to call Technical Support at 1-425-363-5212.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 328
- Distribution
- Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO
- Date initiated
- 2018-07-11
- Date posted
- 2018-08-10
- Date terminated
- 2024-03-20
- 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 |