Leica ARveo and M530 OH6 Microscope Systems Recalled for Voltage Issues
Leica Microsystems is recalling ARveo and M530 OH6 microscope systems because voltage changes may cause equipment shutdown, potentially interrupting surgical procedures.
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 involves a risk of interrupting surgical procedures, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Leica Microsystems, Inc. is recalling Leica ARveo and M530 OH6 microscope systems. The recall is due to a potential unintended interruption of surgical procedures caused by equipment shutdown related to changes in voltage.
A total of 77 devices were distributed, with 65 units distributed domestically across 24 states and the District of Columbia, and 12 units distributed internationally to Japan. The affected devices include specific serial numbers for Model # 10448680 (M530 OH6) and Model # 10448999 (Arveo).
The FDA has classified this recall as Class II, indicating a situation where 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. Users should contact Leica Microsystems for instructions on how to address the voltage-related shutdown risk.
The recalled product
- Product
- Leica ARveo and M530 OH6 microscope systems.
- Manufacturer
- Leica Microsystems, Inc.
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)
- M530 OH6 Serial Numbers for Model # 10448680 OH6-016215
- OH6-042317
- OH6-032016
- OH6-009815
- OHA-010719
- OHA-011919
- OHA-000818
- OHA-009119
- OHA-000718
- OHA-014919
- OHA-016619
- OHA-015919
- OHA-007818
- OHA-013519
- OHA-001218
- OHA-012219
- OHA-017319
- OHA-000418
- OHA-017119
- OHA-013719
Distribution
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