Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period

FDA device recall Z-0182-2012 · posted 2011-11-10 · Terminated

Recall details

Recalling firm

Philips Medical Systems

Reason for recall

A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.

Action taken

Philips sent all affected sites an Urgent Medical Device Correction Letter on September 27, 2011 for the MUGA issue. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy of the communication with the equipment instruction for use. Additionally, a field change order was released on September 26, 2011, customers will be receiving release notes as part of their correction informing them of the changes and corrections to the software. The new software will be installed on affected units by Philips Field Service Engineers. For customers in North America contact Customer Care Solutions Center at 1-800-722-9377. Select option 5. In all other countries contact the local Philips Healthcare office.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

1181 systems

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2011-09-15

Date posted

2011-11-10

Date terminated

2013-01-30

Location

San Jose, CA

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