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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Medical Systems USA

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  Class 2 Device Recall Maquet Medical Systems USA see related information
Date Initiated by Firm October 05, 2016
Create Date November 10, 2016
Recall Status1 Terminated 3 on February 02, 2018
Recall Number Z-0390-2017
Recall Event ID 75386
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product Accessory Adapter Part number 600525A0

Product Usage:
designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Code Information 600525A0
Recalling Firm/
Manufacturer		 Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Maquet Customer Service
888-627-8383
Manufacturer Reason
for Recall		 Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Maquet Medical Systems USA sent an Urgent Product Recall Medical Device Removal letter dated October 5, 2016 to the affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Read this Medical Device Removal Notice and disseminate the information provided to all the users of the device. 2. Examine your inventory immediately to determine if you have the Accessory Adapter(s). If so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet. 3. Please fill out and sign the enclosed Medical Device Removal Response Form on page 4 and return it either via email to FieldActions@maquet.com or fax to 1-973-909-9927. For question contact your local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Press option 2, then followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EDT.
Quantity in Commerce 9 Units (US) 141 Units (OUS)
Distribution Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
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.
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