Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can b

FDA device recall Z-0360-2016 · posted 2015-12-12 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

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.

Action taken

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 attention is necessary to notice the potential failure case early. All affected users should be informed. Customers can contact Michael Kelhart at 1-800-543-5047, (press 1 at the prompt, then 2, then 32349), with questions pertaining to the letter. Contact Drager Service Technical Support at 1-800-543-5047 for questions regarding the operation or servicing of the Drager Perseus A500.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BSZ

Quantity affected

34

Distribution

US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.

Date initiated

2015-11-12

Date posted

2015-12-12

Date terminated

2017-04-05

Location

Telford, PA

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