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 Recall Z-1216-2012 · Posted 2012-03-15
Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2012-02-14
Date Terminated2020-09-23
Product Quantity60 units
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
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.