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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71848

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carestream Health Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2449-2015
Recall number
Z-2449-2015
Initiated
August 07, 2015
Classification
Class II
Status
Terminated
Recalling firm
Carestream Health Inc
Quantity
Domestic: 76 units, Foreign: 160 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.

Field note

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