Medical device software c4D fails to change site upon synchronization
C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.
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: This is an FDA Class II recall involving software malfunction in a medical device. Although no injuries have been reported, the synchronization failure in positioning software represents a risk-of-harm product because the configuration defect could prevent proper device operation and setup.
Plain-English summary
C-RAD POSITIONING AB is recalling PC Application Software c4D (Catalyst: SP-002, part number PA-003), versions 6.1.1 and 6.1.0. This software is part of a medical device positioning system.
The software contains a defect that prevents the Site field from updating properly during synchronization in the Setup workflow step. This malfunction may result in incorrect system configuration and could prevent the device from being properly configured for use.
The recall affects approximately 7 units that were distributed nationwide to customers in Illinois, Kentucky, Missouri, and Washington. Customers should contact C-RAD POSITIONING AB for a corrected software version and should not use affected units until the update is applied.
The recalled product
- Product
- PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
- Manufacturer
- C-RAD POSITIONING AB
- Category
- Medical Device
- Affected units
- 7
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 (2)
- Catalyst: SP-002
- Software (part number): PA-003 version 6.1.1 and 6.1.0
Distribution
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