Recalls / —

—#107557

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)

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K031535

Affected lot / code info

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

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Philips Healthcare Inc.

Address

3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern

Worldwide Distribution - USA Nationwide

Timeline

Recall initiated

2012-02-14

Posted by FDA

2012-03-15

Terminated

2020-09-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #107557. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.