Z-1738-2017Class II

DX-D600 - DXD Imaging Package

Name: Z-1738-2017 DX-D600 - DXD Imaging Package
Creator: AGFA Healthcare Corp.
Published: 2016-05-02
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2016-05-02 / Terminated / root cause: labeling and UDI

FDA source

AGFA Healthcare Corp. began a recall of DX-D600 - DXD Imaging Package on 2016-05-02. FDA classified it as Class II and gives the reason as "One of the dent markers from the DX-D600 dropped down from the overhead rail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1738-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2017-04-05
Terminated: 2017-04-10
Recalling firm: AGFA Healthcare Corp.
Product: DX-D600 - DXD Imaging Package
Product code: KPR System, X-Ray, Stationary
Reason for recall: One of the dent markers from the DX-D600 dropped down from the overhead rail.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On May 2, 2016, an "URGENT FIELD SAFETY NOTICE" letter was either emailed or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment to be sent back. The letter described background information and actions to be taken.
Quantity in commerce: 81 units
Distribution: AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada
Product codes and lots: A5430000264, A5430000272, A5430000162, A5430000238, A5430000226, A5430000137, A5430000306, A6430000298, A5430000299, A5430000246, A5430000247, A5430000249, A5430000303, A5430000228, A5430000229, A5430000304, A5430000234, A5430000276, A5430000285, A5430000296, A5430000300, A5430000015, A5430000124, A5430000125, A5430000095, A5430000144, A5430000156, A5430000206, A5430000207, A5430000061, A5430000100, A5430000053, A5430000079, A5430000225, A5430000248, A5430000027, A5430000030, A5430000042, A5430000052, A5430000066, A5430000068, A5430000081, A5430000085, A5430000096, A5430000131, A5430000132, A5430000224, A5430000297, A5430000166, A5430000222, A5430000054, A5430000263, A5430000057, A5430000119, A5430000133, A5430000176, A5430000177, A5430000184, A5430000295, A5430000275, A5430000279, A5430000107, A5430000108, A5430000293, A5430000063, A5430000020, A5430000074, A5430000045, A5430000121, A5430000089, A5430000143, A5430000218, A5430000199, A5430000149, A5430000060, A5430000165, A5430000067, A5430000130, A5430000305, A5430000215, A5430000237, A5430000058, A5430000105, A5430000106, A5430000172, A5430000183, A5430000242, A5430000281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1738-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05

Product code KPR

K112670Class IIDx-D 600Agfa Healthcare N.V. / cleared 2011-10-27

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)