Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts
Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where a heavy component detached from its mounting, posing a significant risk of injury or property damage, which aligns with the 'Severe' criteria for structural defects and significant injury reports.
Plain-English summary
Carestream Health, Inc. is recalling 589 Kodak DirectView DR 7500 Diagnostic X-Ray Systems. These are permanently installed diagnostic x-ray systems used for examining various anatomical regions. The systems were distributed worldwide, including in the United States and numerous international locations.
The recall was initiated after an on-site evaluation by Carestream Health Service Engineering revealed that the tab on the lock washer attaching the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was not bent into the lock nut recess. Consequently, the lock nut was not sufficiently tightened, causing the Beta Assembly to detach from the OTC telescope.
Healthcare facilities that have purchased or installed these systems should contact Carestream Health for further instructions on how to resolve the issue. The device can be tracked using the service code 8087.
The recalled product
- Product
- Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary…
- Manufacturer
- Carestream Health, Inc.
- Affected units
- 589
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Carestream Health, Inc.
See all →- HighDRX Revolution Mobile X-Ray System Electrical Component Failure Recall
FDA (Devices) · 2023-12-13
- HighDRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
FDA (Devices) · 2023-11-15
- HighX-ray System Overhead Crane May Continue Moving Unexpectedly
FDA (Devices) · 2023-03-08
- HighCarestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement
FDA (Devices) · 2020-01-22
- ModerateCarestream OnSight 3D Extremity System Recalled for Software Data Error
FDA (Devices) · 2019-05-01
Same hazard · structural defect
See all →- SevereVolvo Recalls EX30 and EX30CC Vehicles for Head Restraint Defect
NHTSA · 2026-10-09
- Severe
- Severe
- SevereONTHEWEI Recalls Baby Bath Seats Due to Drowning Risk
CPSC · 2026-10-08
- SevereDecathlon Recalls Van Rysel GRVL AF Bicycles Due to Crash Hazard
CPSC · 2026-10-08
Similar recalls
- HighCarestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled
FDA (Devices) · 2014-01-29
- HighCarestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk
FDA (Devices) · 2014-01-29
- HighCarestream Recalls Kodak DirectView DR 7500 Dual Detector Systems
FDA (Devices) · 2014-02-05
- HighCarestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement
FDA (Devices) · 2020-01-22
- HighCarestream DRX-Evolution X-Ray Systems Recalled for Unexpected Movement
FDA (Devices) · 2014-01-29
- HighCarestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure
FDA (Devices) · 2014-08-13