Z-2949-2011

BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the...

Name: Z-2949-2011 BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the...
Creator: Philips Medical Systems
Published: 2011-06-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-06-15 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting... on 2011-06-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2949-2011
Status: Terminated
Initiated: 2011-06-15
Posted: 2011-08-04
Terminated: 2013-02-15
Recalling firm: Philips North America LLC
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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).
Quantity in commerce: 213 units
Distribution: 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.
Product codes and lots: Model Number: 4535-607-49161. Catalog # 882482. Running system 2.0.1.

Product code KPS

K080927Class IIBrightview Vct Imaging SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2008-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)