Recall Z-0565-2013 ยท BSZ Gas-Machine, Anesthesia
Del Mar Reynolds Medical, Ltd.
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
| Date | Dec 19, 2012 (initiated Nov 2, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| Action | 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 |
| Quantity | 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 Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 Blease Medical Equipment , Ltd., May 23, 2001 |