Z-0390-2017Class II

Accessory Adapter Part number 600525A0

Name: Z-0390-2017 Accessory Adapter Part number 600525A0
Creator: Maquet Medical Systems USA
Published: 2016-10-05
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2016-10-05 / Terminated / root cause: manufacturing process

FDA source

Maquet Medical Systems USA began a recall of Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before... on 2016-10-05. FDA classified it as Class II and gives the reason as "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". 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-0390-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-11-10
Terminated: 2018-02-02
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: FQO Table, Operating-Room, Ac-Powered
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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
Product codes and lots: 600525A0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0390-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0390-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)