Thuvera Laser Console Software Version 2.2 Recall Notice
IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.
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 FDA classified this as a Class II recall. The source text documents a software anomaly causing false error display with no reported injuries or hospitalization, meeting the criterion for Moderate severity.
Plain-English summary
IPG Medical Corporation is recalling the Thuvera Laser Console, Model No. MD2300F-001507, Software Version 2.2, a portable thulium fiber laser device. The recall is due to a software anomaly that causes the device to falsely display error code 5018.
The affected devices include 198 units with specific serial numbers distributed nationwide in the state of Massachusetts. The device is identified by UDI-DI 00810071230226.
Customers who have received this device should contact IPG Medical Corporation for instructions on how to address this issue. The FDA classified this as a Class II recall.
The recalled product
- Product
- Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
- Manufacturer
- IPG Medical Corporation
- Affected units
- 198
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)
- Model No. MD2300F-001507
- UDI-DI 00810071230226
- Serial No. MDUF250342
- MDUF250400
- MDUF250429
- MDUF250060
- MDUF250061
- MDUF250067
- MDUF250068
- MDUF250069
- MDUF250071
- MDUF250076
- MDUF250083
- MDUF250086
- MDUF250091
- MDUF250092
- MDUF250104
- MDUF250131
- MDUF250133
- MDUF250134
Distribution
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