CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report

Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers recalled

Carestream Health is recalling Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, distributed nationwide in the US. The recall was initiated on 24 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD

Quantity recalledDomestic: 347 units (total for both)

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-1128-2014
FDA event ID: 67349
Recalling firm: Carestream Health, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2014
FDA classified: 4 Mar 2014
Reported: 12 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

24 Jan 2014	Recall initiated by company
4 Mar 2014	Classified by FDA	+39 days
12 Mar 2014	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

Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

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

Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

Where it was distributed

Worldwide distribution. USA (nationwide) and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

Which lots are affected?

Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD

Where was it sold?

Worldwide distribution. USA (nationwide) and the country of Canada.

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 67349

This product is part of a recall event; the main page for the event is Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers recalled.

Reported	Class	Recall	Company	Reason	Where
12 Mar 2014	CLASS II	Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers recalled	Carestream Health	Device Malfunction	Nationwide

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