—#102056

Product

BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080927
Affected lot / code info: Model Number: 4535-607-49161. Catalog # 882482. Running system 2.0.1.

Why it was recalled

Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).

Recalling firm

Firm: Philips Medical Systems
Address: 3860 N 1st St, San Jose, California 95134-1702

Distribution

Distribution pattern: Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.

Timeline

Recall initiated: 2011-06-15
Posted by FDA: 2011-08-04
Terminated: 2013-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.