CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Imris ORT300, Removable Operating Room Table, Part Numbers recalled
Deerfield Imaging is recalling Imris ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600. 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-1266-2018
- FDA event ID
- 79488
- Recalling firm
- Deerfield Imaging, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 28 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 28 Mar 2018 | Classified by FDA | +33 days |
| 4 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
Product as listed by the FDA
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Where it was distributed
US, Canada, China, Australia, Sweden, Germany
Questions about this recall
Why was it recalled?
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
Which lots are affected?
(a) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841, 10002255, 10005613 (b) 114093-600, Serial Numbers: 10007411, 10002996, 10004515
Where was it sold?
US, Canada, China, Australia, Sweden, Germany
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79488| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Imris ORT200, Removable Operating Room Table, Part Numbers recalled | Deerfield Imaging | Other | MN | |
| CLASS II | Imris T2X Table, Part Numbers: (a) recalled by Deerfield Imaging | Deerfield Imaging | Other | MN | |
| CLASS II | Imris ORT100 Table, Part Numbers: (a) 110470-000 (b) recalled | Deerfield Imaging | Other | MN |
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 | CT, MA, VA |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |