Z-1216-2012

Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034

Name: Z-1216-2012 Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034
Creator: Philips Healthcare Inc.
Published: 2012-02-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-02-14 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system... on 2012-02-14. The reason FDA records is "Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1216-2012
Status: Terminated
Initiated: 2012-02-14
Posted: 2012-03-15
Terminated: 2020-09-23
Recalling firm: Philips North America LLC
Product: Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system (computed radiography x-ray system)
Product code: KPR System, X-Ray, Stationary
Reason for recall: Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent Medical Device Correction letter dated February 8, 2012 to all affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter contains important information for continue safe and proper use of the equipment. Philips will contact customers to schedule the installation of the updated software. For further information or support contact your local Philips representative at the Technical Support Line 866-767-2822.
Quantity in commerce: 60 units
Distribution: Worldwide Distribution - USA Nationwide
Product codes and lots: DRF systems with software reI 3.0 and 3.1 S/N: 362600 362601 364209 364210 375245 375850 376439 416254/SN09000007 417890/SN08000120 384396 401281/SN08000142 399440 387492 399621 398185 423047 399623 422094 422823 412477/SN08000137 425981 402409 402410/SN08000112 428620 428623 426466 426467 404548/SN08000110 417116/SN08000126 410563/SN08000120 408593/SN08000103 408592/SN08000111 408237/SN08000115 409087/SN08000107 435412 413514/SN08000123 413831/SN08000122 422648 422650 422652 414463 416393/SN08000140 416643/SN09000005 420212 421780 420872/SN09000003 425745 425744 427503 435926 430916 H706034090029 429498 431820 435419 439922 432277 435422

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