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Terminated

Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.

FDA Recall Z-1283-2012 · Posted 2012-03-23

Recalling FirmPhilips Medical Systems Gmbh, DMC
Recall StatusTerminated
Product CodeJAA
Date Initiated2012-03-09
Date Terminated2013-05-23
Product Quantity88 units

Reason for Recall

Underexposed image due to lag in switching between auxiliaries

Firm Action

Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031535PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co. · 2003-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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