Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobil

FDA device recall Z-1689-2012 · posted 2012-05-30 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

Unexpected Low-level X-ray pulse

Action taken

Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Communicate with Philips with regard to this program, please reference Field Change Order 70400049. Further questions please contact your local Philips representative at 1-800-722-9377. On 2/6/15, Philips reported that the recall was extended to an additional 88 units that were unit stock that did receive the correction. Philips issued recall notifcation letter (FCO70400049) on 1/20/2015 to users. Control boards will replaced by a Philips Service Engineer.

Root cause

Device Design

Status

Terminated

Product code

IZL

Quantity affected

10 US; 66 internattional

Distribution

Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong,

Date initiated

2012-05-02

Date posted

2012-05-30

Date terminated

2017-01-18

Location

Andover, MA

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