Getinge Meera Mobile Operating Table Recalled for Electric Shock Risk
Maquet Cardiovascular is recalling Getinge Meera Mobile Operating Tables because exposed electronic components may cause electric shock to users.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of electric shock, which constitutes a significant injury risk. Per the rubric, FDA Class II recalls with potential for significant injury are rated as Severe (4).
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling specific models of the Getinge Meera Mobile Operating Table. The recall involves seven part numbers: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, and 710001F0. The product is designed to support and position patients before, during, and after surgical interventions, as well as for examination and treatment.
The recall was initiated because users may suffer an electric shock when coming into contact with exposed electronic components on the device. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, a violation of product labeling or manufacturing standards may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recall affects 163 units in the United States and 1,864 units in foreign countries. The distribution pattern includes nationwide distribution in the US and distribution to numerous countries worldwide, including Canada, the United Kingdom, Germany, France, and Japan. Affected serial number ranges are specified for each part number in the source documentation. Healthcare facilities and users should stop using the affected units and contact the manufacturer for instructions on repair or replacement.
The recalled product
- Product
- GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
Distribution
Distributed nationwide across the United States.
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