Brainlab Patient Data Manager Software Recalled for Image Display Errors
Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.
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 is classified as FDA Class II, and the hazard involves potential misdisplay of medical images, which poses a risk of harm to patients if relied upon for clinical decisions, even though specific injuries are not reported in the source text.
Plain-English summary
Brainlab AG is recalling the Patient Data Manager software, a system intended for the display of medical images. The recall covers versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, and 2.1.0. The software is used to transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media, and includes functions for image manipulation, basic measurements, and 3D visualization.
The recall is due to a defect where objects may be incorrectly displayed when a user actively deselects a fused reference dataset. The software is not intended for primary image diagnosis or the review of mammographic images. The affected units were distributed worldwide, including the United States and numerous other countries.
Healthcare facilities and users of the affected software versions should contact Brainlab AG for instructions on how to resolve the issue. The recall number is Z-0218-2016.
The recalled product
- Product
- Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or…
- Manufacturer
- Brainlab AG
- Affected units
- 897
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 (4)
- Potentially affected are Patient Data Manager versions 2.0.0
- 2.0.1
- 2.0.2
- 2.0.3
Distribution
Distributed nationwide across the United States.
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