Reported Sep 2, 2015 · Terminated
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for…
Carestream Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health Inc · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
- CARESTREAM DRX-EVOLUTION
- X-Ray System Product UsageThe device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients
- Lot codes and dates
- Software versions 5.6 and greater and 5.7 (current releases)
- Serial Numbers
174 of 174 codes
502955694067475441314100409640764569457045884670476748795266539354085442557255735555555655634146467947024703470448015090515447874069407443444085405840845470515840864099407346655241530353044639535053525429550846964763518242915037555441924117
- NOTEAdditional serial numbers at foreign consignees to be determined upon reporting part usage
- Amount recalled
- Domestic: 76 units, Foreign: 160 units
Where it was sold
- Nationwide
Why it was recalled
Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Carestream Health Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.