CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Imris ORT 100 table, Part Numbers: (a) 110470-000, (b) recalled

Deerfield Imaging is recalling Imris ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600, distributed nationwide in the US. The recall was initiated on 6 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343

Quantity recalled27 units

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-0646-2019
FDA event ID: 81574
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2018
FDA classified: 20 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

6 Nov 2018	Recall initiated by company
20 Dec 2018	Classified by FDA	+44 days
26 Dec 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Table may drift in the roll position while in use

Product as listed by the FDA

IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Where it was distributed

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

Nationwide

Questions about this recall

Is Imris ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 recalled?

Yes. Deerfield Imaging recalled Imris ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 on 6 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0646-2019.

Why was it recalled?

Table may drift in the roll position while in use

Which lots are affected?

(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343

Where was it sold?

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

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.

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