Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables
Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because their rotational locking mechanisms may fail to operate, preventing the table from changing between locked and unlocked states.
What this means for you
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 is classified as FDA Class II. The hazard involves a mechanical failure in a medical device used during surgical procedures, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Deerfield Imaging, Inc. is recalling 13 units of the IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version. The product is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
The recall is due to a defect in the rotational locking mechanisms on the ORT 200/300 tables. These mechanisms may fail to operate, which prevents the table from changing states between locked and unlocked. The affected units were distributed in the US, Canada, China, Sweden, Germany, Japan, Qatar, France, and Australia.
Healthcare facilities should stop using the affected devices and contact Deerfield Imaging for instructions on corrective action. The specific serial numbers for the recalled units are: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, and 10002255.
The recalled product
- Product
- IMRIS ORT300 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
- 13
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 (13)
- Serial numbers: 10005695
- 10002998
- 10005456
- 10007411
- 10007377
- 10002997
- 10002996
- 10005612
- 10004372
- 10002841
- 10004515
- 10005613
- 10002255
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.
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