Recall Z-0360-2016 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
| Date | Dec 12, 2015 (initiated Nov 12, 2015) |
| Status | Terminated |
| Reason | There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm. |
| Root cause | Nonconforming Material/Component |
| Action | Draeger Medical, Inc. sent Urgent Medical Device Recall Letters, dated November 2015, to consignees on November 10, 2015. The letter identified the affected device and the reason for the recall. The device power switch of the affected workstations must be replace. Customers should refer to the list of affected serial numbers provided. A Drager Service Representative will contact customers to schedule the replacement free of charge, as soon as new switches are available. Until the replacement takes place, the workstation may only be operated under continuous supervision. Increased attenti |
| Quantity | 34 |
| Distribution | US Distribution -- To the states of WI, PA, OH, ME, IL, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133886 | PERSEUS A500 Draeger Medical GmbH, Jun 20, 2014 |