Z-0365-2016Class II

Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

Name: Z-0365-2016 Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Creator: Philips Medical Systems, Inc.
Published: 2014-08-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-08-19 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050 on 2014-08-19. FDA classified it as Class II and gives the reason as "The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient". 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-0365-2016
Classification: Class II
Status: Terminated
Initiated: 2014-08-19
Posted: 2015-12-03
Terminated: 2016-06-14
Recalling firm: Philips North America LLC
Product: Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Product code: KPR System, X-Ray, Stationary
Reason for recall: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Root cause tag: design
FDA root cause: Device Design
Action: The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.
Quantity in commerce: 260 units, not all units have the patient support accessory
Distribution: Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Product codes and lots: All patient support for stitching are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0365-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0364-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-03
Z-0365-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-03

Product code KPR

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)