CooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction Risk
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may fail to cut, coagulate, or blend during 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 involves a high-risk medical device where a functional failure could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 110 units of the Quantum 2000 Electrosurgical Generator, part numbers 909075, 909075-05, and 909075-05W. The recall was initiated because the devices have the potential to cease cutting, coagulating, or blending during a procedure when the foot pedal is used for activation.
The affected units were distributed to 29 states in the United States and four international countries: China, Indonesia, South Africa, and Tanzania. The specific serial numbers for the recalled units range from 2015120001 to 2017080010, with specific blocks listed in the official recall documentation.
Healthcare facilities and users should check their inventory for the affected serial numbers and contact CooperSurgical for instructions on how to proceed with the recall.
The recalled product
- Product
- Quantam 2000 Electrosurgical Generator, Part number 909075-05.
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 110
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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