CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Imris ORT300 Removable Operating Room Table, 50-60 Hz recalled
Deerfield Imaging is recalling Imris ORT300 Removable Operating Room Table, 50-60 Hz. The recall was initiated on 23 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1218-2018
- FDA event ID
- 79366
- Recalling firm
- Deerfield Imaging, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 27 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 27 Mar 2018 | Classified by FDA | +32 days |
| 4 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Questions about this recall
Is Imris ORT300 Removable Operating Room Table, 50-60 Hz recalled?
Yes. Deerfield Imaging recalled Imris ORT300 Removable Operating Room Table, 50-60 Hz on 23 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1218-2018.
Why was it recalled?
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Which lots are affected?
Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255
Where was it sold?
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Deerfield Imaging
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trumpf Mount Clamp Assembly (table adapter component) recalled | Deerfield Imaging | Other | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | iMRX MRI and Angiography System recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
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