Z-2175-2014Class II

DX-D 600 - DXD Imaging Package

Name: Z-2175-2014 DX-D 600 - DXD Imaging Package
Creator: AGFA Healthcare Corp.
Published: 2014-07-02
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-07-02 / Terminated / root cause: design

FDA source

AGFA Healthcare Corp. began a recall of DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be... on 2014-07-02. FDA classified it as Class II and gives the reason as "Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2175-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-02
Posted: 2014-08-10
Terminated: 2015-06-04
Recalling firm: AGFA Healthcare Corp.
Product: DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
Root cause tag: design
FDA root cause: Device Design
Action: AGFA HealthCare sent an URGENT FIELD SAFETY NOTICE letter dated July 2, 2014 to affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgment form, via FAX-Back or email. A Mandatory Service Bulletin DIS012.14E/No. 32, was released June 30, 2014, to implement the mandatory upgrade of full automatic DX-D600 systems to version 3.6 to prevent unexpected system movements. This Mandatory Service Bulletin was issued to Agfa DR Specialists to perform the service. A 2nd release will be implemented to upgrade semi-automatic systems. For questions contact your local AGFA HealthCare organization 1-877-777-2432.
Quantity in commerce: 17 units
Distribution: Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
Product codes and lots: Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2175-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2175-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-09

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)