CooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures when the foot pedal is used.
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. The hazard involves a device malfunction during a procedure, which poses a risk of harm, but the source text does not report any specific injuries, hospitalizations, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling the Quantum 2000 Electrosurgical Generator, part numbers 909075, 909075-05, and 909075-05W. The recall involves four units distributed across 29 U.S. states and four international countries, including China, Indonesia, South Africa, and Tanzania.
The recall is due to a potential for the device to cease cutting, coagulating, or blending during a procedure when the foot pedal is used for activation. This malfunction could impact the intended surgical function of the equipment.
Healthcare facilities and users should contact CooperSurgical, Inc. for instructions on how to address the affected units. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 3 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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