Z-2449-2015Class II

CARESTREAM DRX-EVOLUTION X-Ray System

Name: Z-2449-2015 CARESTREAM DRX-EVOLUTION X-Ray System
Creator: Carestream Health Inc
Published: 2015-08-07
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2015-08-07 / Terminated / root cause: software

FDA source

Carestream Health Inc began a recall of CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging... on 2015-08-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2449-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Posted: 2015-08-22
Terminated: 2016-07-06
Recalling firm: Eastman Kodak Company
Product: CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The 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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Carestream sent an Urgent Medical Device Correction letters dated July 29, 2015 and Customer Notification Acknowledgement Forms to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Carestream will update the software on your device to correct this issue. For questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number.
Quantity in commerce: Domestic: 76 units, Foreign: 160 units
Distribution: Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Product codes and lots: Software versions 5.6 and greater and 5.7 (current releases); Serial Numbers: 5029, 5569, 4067, 4754, 4131, 4100, 4096, 4076, 4569, 4570, 4588, 4670, 4767, 4879, 5266, 5393, 5408, 5442, 5572, 5573, 5555, 5556, 5563, 4146, 4679, 4702, 4703, 4704, 4801, 5090, 5154, 4787, 4069, 4074, 4344, 4085, 4058, 4084, 5470, 5158, 4086, 4099, 4073, 4665, 5241, 5303, 5304, 4639, 5350, 5352, 5429, 5508, 4696, 4763, 5182, 4291, 5037, 5554, 4192, 4117, 4172, 4207, 4225, 4239, 4278, 4301, 4310, 4328, 4333, 4338, 4366, 4384, 4421, 4427, 4442, 4443, 4447, 4465, 4499, 4523, 4534, 4538, 4539, 4692, 4822, 4861, 4875, 5128, 5131, 5174, 5553, 5579, 5580, 5597, 5628, 4320, 5309, 5042, 4807, 4808, 4809, 4810, 5493, 4266, 4711, 5327, 4125, 4143, 4097, 4156, 4282, 4287, 4289, 4258, 4742, 4964, 4784, 5050, 5551, 4233, 4644, 4082, 4113, 4196, 4683, 4309, 4315, 4064, 4256, 4987, 4624, 4585, 4882, 5362, 4004, 5377, 5418, 4300, 4308, 4627, 4638, 5138, 5251, 5360, 4947, 5620, 4985, 5403, 5495, 5560, 5544, 5545, 5621, 5622, 5451, 5282, 5645, 4724, 4298, 4269, 4756, 4418, 5273, 5178, 5179, 5443, 5197, 5389, 5584, 5473, 4899, 5334, 5431, 4990 --- NOTE: Additional serial numbers at foreign consignees to be determined upon reporting part usage.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2449-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code KPR

K141837Class IIDrx-EvolutionCarestream Health, Inc. / cleared 2015-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)