Leica M530 OHX Microscope System Recalled for Power Module Design Weakness
Leica Microsystems is recalling 123 M530 OHX Microscope Systems due to a design weakness in the power insert module.
What this means for you
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. Per the rubric, FDA Class II recalls without explicit hospitalization reports or structural vehicle defects are typically rated High (3), especially when the hazard is a design weakness in a medical device where injury has not yet been reported.
Plain-English summary
Leica Microsystems, Inc. is recalling 123 Leica M530 OHX Microscope Systems supplied with 100 - 120 Vac. The recall is due to a design weakness of the power insert module.
The affected devices were distributed in the United States (including Puerto Rico) and internationally to Japan, Brazil, Colombia, Ecuador, Mexico, and Taiwan. The source text does not specify the exact actions consumers or healthcare facilities should take, such as stopping use or contacting the manufacturer, but the recall is active under FDA oversight.
This recall is classified as Class II by the FDA. No specific injuries, illnesses, or deaths are reported in the source text.
The recalled product
- Product
- Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
- Manufacturer
- Leica Microsystems, Inc.
- Category
- Medical Device — Microscope
- Hazard
- Affected units
- 123
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)
- US: 90116001
- 30118001
- 51215001
- 201117001
- 30916001
- 270216001
- 100917001
- 31117001
- 00817001
- 0316001
- 31217001
- 180118001
- 200218001
- 151217001
- 21217001
- 21214001
- 80218001
- 170118001
- 01017002
- 101017001
Distribution
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