Philips Digital Diagnost Stationary radiographic system

FDA device recall Z-0900-2013 · posted 2013-03-01 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

Action taken

Philips Healthcare issued an Urgent Field Safety Notice dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review the information contained in the Notice with all member of their staff who need to be aware of the contents. Also, customers were asked to retain a copy with the equipment Instruction for Use. For further information or questions customers were instructed to contact their local Phillips representative Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-659-4519.

Root cause

Software design

Status

Terminated

Product code

MQB

Quantity affected

360

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Ar

Date initiated

2012-10-30

Date posted

2013-03-01

Date terminated

2013-07-29

Location

Andover, MA

Related 510(k) clearances