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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 19 FDA device recalls.

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DateProductReasonClassFirm
Feb 17, 2022 Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a co... Reports have been received that after normal or routine lateral forces are applied to the head fi... Class II Deerfield Imaging, Inc.
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Nov 26, 2019 iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgica... There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue... Class II Deerfield Imaging, Inc.
Jun 26, 2019 IMRIS MR/X-ray head fixation device, Model HFD200 Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond ... Class II Deerfield Imaging, Inc.
Nov 6, 2018 IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000,... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Nov 6, 2018 IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product ... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Nov 6, 2018 IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000,... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Nov 6, 2018 IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, ... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Apr 4, 2018 IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative M... The DC power to the IFOSS collision detector control panel at your facility is being adversely af... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for... The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot c... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600 The Operating Room Table may drift while in use, which could potentially result in unintended mov... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-00... The Operating Room Table may drift while in use, which could potentially result in unintended mov... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for... The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot c... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 ... The Operating Room Table may drift while in use, which could potentially result in unintended mov... Class II Deerfield Imaging, Inc.
Feb 23, 2018 IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 ... The Operating Room Table may drift while in use, which could potentially result in unintended mov... Class II Deerfield Imaging, Inc.
Feb 20, 2018 IMRIS ORT100 Table, Part Number 110470-000 The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... Class II Deerfield Imaging, Inc.
Feb 20, 2018 IMRIS T2X Table, Part Number 109682-600 The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... Class II Deerfield Imaging, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.