FDA Medical Device Recalls (openFDA)
Philips Medical Systems: BrightView X Gamma Camera, 3/8". 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.
- Recall number
- Z-2947-2011
- Recalling firm
- Philips Medical Systems
- Product
- BrightView X Gamma Camera, 3/8". 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.
- Status
- Terminated
- Initiated
- 2011-06-15
- Posted
- 2011-08-04
- Terminated
- 2013-02-15
- Reason
- 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
- 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
- 213 units, all systems
- 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.
- Lot, serial or model codes
- Model #4535-608-24741. Catalog # 882478. Running systems 2.0.1
- 510(k) numbers
- ["K062298"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28