CooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction
CooperSurgical is recalling 105 Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending 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 is classified as FDA Class II and involves a medical device that may fail to perform its intended function during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 105 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 in 29 U.S. states and in China, Indonesia, South Africa, and Tanzania. Specific serial numbers for the recalled units are listed in the official recall documentation. The agency has classified this recall as Class II.
Healthcare facilities and users should stop using the affected devices and contact CooperSurgical, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Quantam 2000 Electrosurgical Generator, Part number 909075.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 105
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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