Philips BrightView Ultrasound Systems Recalled for Software Issues
Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, injuries, or deaths, and the hazard is described generally as 'software issues' without specific high-risk pathogen or structural defect details, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is voluntarily recalling 85 units of BrightView, BrightView X, and BrightView XCT ultrasound systems. The recall was initiated on November 4, 2014, and is classified as Class II by the FDA. The reason for the recall is identified as software issues.
The affected devices were distributed worldwide, including in the United States (specifically in AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX) and in Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. Government facilities in AR, FL, MN, OH, and OK were also affected.
The recall status is terminated as of July 2, 2018. The initial notification to facilities was sent via letter. Specific product codes and serial numbers for the affected units are listed in the official FDA recall record Z-0450-2015.
The recalled product
- Product
- BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- BrightView: 11000022
- 11000028
- 11000050
- 1000067
- 11000070
- 11000073
- 1000079
- 11000080
- 11000084
- 11000088
- and 11000109. BrightView X:4000007
- 4000034
- 4000045
- 4000049
- 4000050
- 4000052
- 4000055
- 4000057
- 4000062
- 4000091
Distribution
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