BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the custome
FDA device recall Z-0565-2013 · posted 2012-12-19 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Reason for recall
- The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.
- Action taken
- Spacelabs has sent the Urgent -Medical Device Correction-Spacelabs Healthcare BleaseFocus Anesthesia Workstation Blease 700/900 Series Ventilators letter, dated 16 November 2012, to US customers. On November 26, 2012, a customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. Customers are advised that the primary alarm will sound only in the event of an O2 supply failure and they will be provided with the corrected user and service manuals that do not reference a secondary O2 supply failure alarm. Customers with questions can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 3 in US and 3121 Outside US
- Distribution
- Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republ
- Date initiated
- 2012-11-02
- Date posted
- 2012-12-19
- Date terminated
- 2013-07-11
- Location
- Hertford, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 (K003251) | Blease Medical Equipment , Ltd. | 2001-05-23 |