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FDA Medical Device Recalls (openFDA)

Maquet Medical Systems USA: 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.

Recall number
Z-0390-2017
Recalling firm
Maquet Medical Systems USA
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.
Status
Terminated
Initiated
2016-10-05
Posted
not on file
Terminated
2018-02-02
Reason
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.
Root cause
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
9 Units (US) 141 Units (OUS)
Distribution
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
Lot, serial or model codes
600525A0
510(k) numbers
not on file
PMA numbers
not on file
Product code
FQO
Firm FEI
3008355164
Firm city
Wayne
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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