CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report

Imris Deerfield Imaging recalled

Deerfield Imaging is recalling Imris Deerfield Imaging, distributed in Illinois, Oregon, Pennsylvania. The recall was initiated on 14 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659

Quantity recalled6 screws

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-3211-2017
FDA event ID: 77996
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 14 Aug 2017
FDA classified: 22 Sep 2017
Reported: 4 Oct 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

14 Aug 2017	Recall initiated by company
22 Sep 2017	Classified by FDA	+39 days
4 Oct 2017	Published in enforcement report	+12 days

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

Reason for recall

incorrect thread on thumbscrews

Product as listed by the FDA

IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

Where it was distributed

IL, OR, PA

Illinois Oregon Pennsylvania

Questions about this recall

Is Imris Deerfield Imaging recalled?

Yes. Deerfield Imaging recalled Imris Deerfield Imaging on 14 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-3211-2017.

Why was it recalled?

incorrect thread on thumbscrews

Which lots are affected?

Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659

Where was it sold?

IL, OR, PA

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

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