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.
What this means for you
Illness, injury, or structural failure has been reported. 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 generator
- Manufacturer
- Carestream Health, Inc.
- Affected units
- 589
Distribution
Distributed nationwide across the United States.
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