Z-2384-2012Class II

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system...

Name: Z-2384-2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system...
Creator: Philips Healthcare Inc.
Published: 2012-08-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-08-14 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications on 2012-08-14. FDA classified it as Class II and gives the reason as "Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm". 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-2384-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-14
Posted: 2012-09-14
Terminated: 2017-01-17
Recalling firm: Philips North America LLC
Product: Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 4 systems
Distribution: Worldwide Distribution - USA including OH and WA and the country of Canada
Product codes and lots: Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2384-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2384-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14

Product code MQB

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)