Medical Device Software Update Recall for 324 MAZOR X Surgical Robots
Mazor Robotics has initiated a voluntary recall of 324 MAZOR X robotic guidance systems (Model TPL0059) due to a software issue requiring update. Affected devices were distributed nationwide in the US.
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: This is a voluntary, firm-initiated, Class II medical device recall with no reported illnesses, injuries, or deaths. The recall is precautionary in nature, requiring a software update. Per the rubric, voluntary precautionary recalls without reported incidents are classified as Moderate (Score 2).
Plain-English summary
The MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1, is subject to a recall affecting 324 devices distributed nationwide in the United States. The system is manufactured by Mazor Robotics Ltd.
Mazor Robotics Ltd initiated this voluntary recall on September 5, 2023, as a firm-initiated action. The recall was issued in response to a software issue identified in the affected devices. A software update is required to address the problem.
The recall affects devices with specific serial numbers across three different product identifiers (GTINs). Users and operators of the affected MAZOR X systems should contact Mazor Robotics Ltd or their healthcare facility for instructions on obtaining and installing the required software update.
For complete information on affected serial numbers and product identifiers, refer to FDA recall number Z-0101-2024.
The recalled product
- Product
- MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
- Manufacturer
- Mazor Robotics Ltd
- Category
- Medical Device — Surgical Robot
- Hazard
- Affected units
- 324
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)
- GTIN 07290109180465
- Serial Numbers: 4000770717
- 4000800717
- 4000810817
- 4000820817
- 4000830817
- 4000840817
- 4000850817
- 4000870817
- 4000880817
- 4000890917
- 4000900917
- 4000910917
- 4000920917
- 4000930917
- 4000940917
- 4000951017
- 4000961017
- 4000971017
- 4000981017
Distribution
Distributed nationwide across the United States.
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