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U.S. Department of Health and Human Services

Class 1 Device Recall Perseus A500 Anesthesia Workstation

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  Class 1 Device Recall Perseus A500 Anesthesia Workstation see related information
Date Initiated by Firm November 12, 2015
Date Posted December 12, 2015
Recall Status1 Terminated 3 on April 05, 2017
Recall Number Z-0360-2016
Recall Event ID 72649
510(K)Number K133886  
Product Classification Gas-machine, anesthesia - Product Code BSZ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact
215-721-5400
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL GMBH
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