Z-2494-2012Class II

Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09...

Name: Z-2494-2012 Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09...
Creator: Philips Healthcare Inc.
Published: 2012-09-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-09-12 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic... on 2012-09-12. FDA classified it as Class II and gives the reason as "Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator". 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-2494-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-12
Posted: 2012-09-28
Terminated: 2013-07-26
Recalling firm: Philips North America LLC
Product: Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377.
Quantity in commerce: 536 units
Distribution: Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,United Arab Emirates and United Kingdom.
Product codes and lots: Serial number range (patient carriage) from: 00 000 00 to 09 000 543.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2494-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2494-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

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)