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FDA device recall Z-0791-2014 · posted 2014-01-29 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.

Action taken

Philips Medical Systems sent a Field Safety Notice letter dated February 25, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. Your Corrective Action Plan (CAP) is approved and consists of: 1. Notifying all affected users with Field Safety Notice 72800527/72800528 starting March 8, 2011. This Field Safety Notice has been reviewed and is approved. 2. Following up with all responses by dispatching a Field Service engineer to each site to install the software update at no cost to the user. 3. Tracking the responses from users by certified mail. For further questions please call (440) 483-7600.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

23

Distribution

Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The N

Date initiated

2011-03-07

Date posted

2014-01-29

Date terminated

2014-04-28

Location

Cleveland, OH

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