Z-2208-2012Class II

Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032...

Name: Z-2208-2012 Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032...
Creator: Philips Healthcare Inc.
Published: 2012-07-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-07-11 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for... on 2012-07-11. FDA classified it as Class II and gives the reason as "Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors". 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-2208-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Posted: 2012-08-15
Terminated: 2017-01-23
Recalling firm: Philips North America LLC
Product: Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
Product code: IXR Table, Radiographic, Tilting
Reason for recall: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501
Quantity in commerce: 12 units
Distribution: Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.
Product codes and lots: Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2208-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2208-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code IXR

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)