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Terminated

Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option

FDA Recall Z-1353-06 · Posted 2006-08-03

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-07-01
Date Terminated2008-05-21
Product Quantity157 devices

Reason for Recall

Potential for measurements, lines, texts, etc to be stored incorrectly.

Firm Action

On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033088SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1Sectra AB · 2003-10-29

Official Source

View FDA Recall →

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

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