Z-0360-2016Class I

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

Name: Z-0360-2016 Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and...
Creator: Draeger Medical, Inc.
Published: 2015-11-12
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2015-11-12 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual... on 2015-11-12. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0360-2016
Classification: Class I
Status: Terminated
Initiated: 2015-11-12
Posted: 2015-12-12
Terminated: 2017-04-05
Recalling firm: Draeger, Inc.
Product: 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.
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 34
Distribution: US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
Product codes and lots: ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and ASHK-0087.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0360-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-11

Product code BSZ

K133886Class IIPerseus A500Draeger Medical GmbH / cleared 2014-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)