Philips NeuViz 16 CT Scanner Recall for Patient Data Error
Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a software error could lead to incorrect patient imaging, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Philips and Neusoft Medical Systems Co., Ltd. are recalling 37 units of the NeuViz 16 Multi-Slice CT Scanner System. The recall affects specific serial numbers listed in the agency notice and is limited to systems running software versions 1.1.4.21425 and 1.1.4.21426.
The recall is due to a software defect in the MX 16-slice console. During filming operations, the clipboard used for copying and pasting images is not cleared between patients. If an operator fails to copy the current patient's images before pasting, a previous patient's image may remain in the clipboard and be pasted into the current patient's record.
The affected units were distributed in North Carolina, Ohio, Nebraska, South Carolina, Texas, Louisiana, Puerto Rico, Missouri, Florida, and Connecticut. Healthcare facilities should contact the recalling firm for instructions on how to resolve the software issue.
The recalled product
- Product
- NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
- Manufacturer
- Philips and Neusoft Medical Systems Co., Ltd.
- Affected units
- 37
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)
- Serial Numbers: N16E090002
- N16E090003
- N16E090007
- N16E090008
- N16E090010
- N16E100023
- N16E110023
- N16E110026
- N16E120016
- N16E120023
- N16E120052
- N16E120053
- N16E130012
- N16E130038
- N16E130045
- N16E140008
- N16E140007
- N16E140012
- N16E140017
- N16E140020
Distribution
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