CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Imris ORT100 Table recalled by Deerfield Imaging
Deerfield Imaging is recalling Imris ORT100 Table. The recall was initiated on 20 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-0975-2018
- FDA event ID
- 79360
- Recalling firm
- Deerfield Imaging, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2018
- FDA classified
- 13 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 20 Feb 2018 | Recall initiated by company | |
| 13 Mar 2018 | Classified by FDA | +21 days |
| 21 Mar 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 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
Product as listed by the FDA
IMRIS ORT100 Table, Part Number 110470-000
Where it was distributed
US, Canada, Australia, China, Qatar
Questions about this recall
Why was it recalled?
The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
Which lots are affected?
Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886
Where was it sold?
US, Canada, Australia, China, Qatar
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
1 other product · FDA event 79360This product is part of a recall event; the main page for the event is Imris T2X Table recalled by Deerfield Imaging.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Imris T2X Table recalled by Deerfield Imaging | 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 |
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| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |