Z-0970-2013Class II

CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in...

Name: Z-0970-2013 CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in...
Creator: AGFA Corp.
Published: 2013-02-07
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2013-02-07 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from... on 2013-02-07. FDA classified it as Class II and gives the reason as "The cassettes were shipped with the wrong IP (image plate) size bar code". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0970-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Posted: 2013-03-19
Terminated: 2013-06-06
Recalling firm: AGFA Healthcare Corp.
Product: CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: The cassettes were shipped with the wrong IP (image plate) size bar code.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 7, 2013, AGFA called dealers involved to alert them of the safety issue. Also, an 'URGENT FIELD SAFETY NOTICE" letter dated February 26, 2013 was sent to the customers. The letter described the affected product, problem and actions to be taken. Customers were requested to check their inventories for the affected product and block any identified product within their inventory. Customers were instructed to complete the attached Feedback form and return via FAX or email. For questions call 877-777-2432 Prompt 5.
Quantity in commerce: 17
Distribution: USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
Product codes and lots: Batch No. A2KQMW

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0970-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0970-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code MQB

K121948Class IICr 10-X DigitizerAgfa Healthcare N.V. / cleared 2012-07-20

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)