—#109064

Product

Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042368
Affected lot / code info: Serial numbers: PC1-0504 through PC1 -0588. Extended recall 1/20/2015 (88 units): 484947/SNPC1-0579 375495 423986/SNPC1-0406 423986/SNPC1-0406 423990/SNPC1-0410 465801/SNPC1-0499 465801/SNPC1-0499 365636 365637 365637 365635 392508/SNPC1-0281 479454/SNPC1-0559 352064 352064 323714 455129/SNPC1-0474 423985/SNPC1-0396 423985/SNPC1-0396 411312/SNPC1-0343 411312/SNPC1-0343 328312 328312 345399 345399 345402 345402 345402 380754 380754 424721/SN424721PC1 380965 312998 PC1-0265 314440 314440 386105/SNPC1-0272 425484/SNPC1-0401 425484/SNPC1-0401

Why it was recalled

Unexpected Low-level X-ray pulse

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa,Thailand and Ukraine.

Timeline

Recall initiated: 2012-05-02
Posted by FDA: 2012-05-30
Terminated: 2017-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109064. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.