Deerfield Imaging Recalls ORT200 Operating Room Tables Due to Locking Mechanism Failure
Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because their rotational locking mechanisms fail to operate, preventing the table from changing between locked and unlocked states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could compromise patient safety during procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Deerfield Imaging, Inc. is recalling 17 units of the IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version. The recall is due to a defect in the rotational locking mechanisms, which fail to operate and prevent the table from changing states between locked and unlocked.
The affected tables are intended for use during diagnostic examinations or surgical procedures to support and position a patient. The recall covers units distributed in the US, Canada, China, Sweden, Germany, Japan, Qatar, France, and Australia. Specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities should stop using the affected tables and contact Deerfield Imaging, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
- Manufacturer
- Deerfield Imaging, Inc.
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Serial numbers: 10006997
- 10002692
- 10006152
- 10007192
- 10006991
- 10002220
- 10003754
- 10006997
- 10004513
- 10005201
- 10006891
- 10004463
- 10005189
- 10005190
- 10004327
- 10004997
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Deerfield Imaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Similar recalls
- HighDeerfield Imaging Recalls IMRIS ORT100 Tables Due to Locking Mechanism Defect
FDA (Devices) · 2018-03-21
- HighDeerfield Imaging Recalls IMRIS ORT200 Operating Room Tables for Drift Risk
FDA (Devices) · 2018-04-04
- HighDeerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift
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- HighOperating Room Table Rotational Lock May Fail Due to Hardware Defect
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- HighDeerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables
FDA (Devices) · 2018-12-26
- HighOperating Room Table Rotational Lock May Fail to Function
FDA (Devices) · 2021-10-06