Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure
Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (mechanical failure of a medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Carestream Health, Inc. is recalling the Model Kodak 2200 Intraoral X-Ray System, including catalog numbers 5303177, 5303169, 5303151, and XR-5154323. The recall involves 347 units distributed in the United States and Canada. These systems are permanently installed diagnostic dental x-ray units used for examining teeth, jaws, and oral structures.
The recall was initiated due to problem reports indicating apparent early failure of the device arms, which can lead to arm breakage. The affected units have 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, or YD.
Dental practices and consumers should stop using the affected devices and contact Carestream Health for further instructions on repair or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Carestream Health Inc.
- Affected units
- 347
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers starting with WE
- WF
- WG
- WH
- WI
- WJ
- WK
- WL
- XA
- XB
- XC
- XD
- XE
- XF
- XG
- XH
- XI
- XJ
- XK
- XL
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Carestream Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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