The Recall Desk

FDA (Devices) recall action 66067

Carestream Health Inc. recalled 2 products on 2013-11-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-13
Critical
0
Units
554

Why these products were recalled

Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2013-11-13

    Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall

    Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.

    Product
    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Distribution
    42 states
  • ModerateFDA (Devices)··2013-11-13

    Carestream DRX Mobile X-Ray Systems Recalled for Software Defect

    Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.

    Product
    CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Distribution
    42 states