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Recall Observatory FDA recall evidence

Device product

DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

Z-0132-2014

June 19, 2013

Class II

Product summary

Firm
Carestream Health Inc.
Event
Event 65586
Status
Terminated
Classification
Class II
Quantity
331 units
Official record key
device-enforcement:Z-0132-2014

Official wording

Reason: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

Code information: Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013

Distribution pattern: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.