Aesculap GN200 Caiman HF Generators Recalled for Faulty Component
Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators due to a faulty component that may impact proper device functioning.
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 medical device with a functional defect that could impact proper operation, representing a risk of harm where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators, electrosurgical cutting and coagulation units, and their accessories. The recall was initiated because the generators may contain a faulty component that could impact the proper functioning of the device.
The affected units were distributed nationwide in the United States. The recall covers specific serial numbers listed in the agency documentation, including 1229, 1897, 1898, 1900, 1909, 1911, 1929, 1930, 1932, 1934, 1938, 1993, 1997, 1998, 1999, 2000, 2029, 2030, 2031, 2032, 2037, 2038, 2039, 2040, 2041, 2042, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, and 2168.
Healthcare facilities and users should check their inventory for these specific serial numbers. If a unit is affected, it should be removed from service and the recalling firm contacted for instructions on repair or replacement.
The recalled product
- Product
- GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 24
Distribution
Distributed nationwide across the United States.
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