CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report
Carestream DRX -Mobile Retrofit Kit recalled by Carestream Health
Carestream Health is recalling Carestream DRX -Mobile Retrofit Kit, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0180-2014
- FDA event ID
- 66067
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2013
- FDA classified
- 7 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 29 Aug 2013 | Recall initiated by company | |
| 7 Nov 2013 | Classified by FDA | +70 days |
| 13 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Is Carestream DRX -Mobile Retrofit Kit recalled?
Yes. Carestream Health recalled Carestream DRX -Mobile Retrofit Kit on 29 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0180-2014.
Why was it 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
Which lots are affected?
Model: DRX Mobile Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
Where was it sold?
Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carestream Health
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DRX Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | The DRX-Revolution Mobile X-Ray System is a diagnostic recalled | Carestream Health | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Drx-Compass/Dr-fit X-ray Systems with Firmware recalled | Carestream Health | Other | Nationwide |
| Device | CLASS II | Kodak DirectView DR3000/3500 recalled by Carestream Health | Carestream Health | Lead & Heavy Metals | IA |
| Device | CLASS II | OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled | Carestream Health | Other | Nationwide |
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