CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness
Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a medical device with a software malfunction. The source text explicitly states only the technical problem (unresponsive touch screen) with no reported illnesses or injuries, making it a moderately-severity concern rather than high or severe.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the CUSA Clarity C7000 Console, Software Version 2.1.1.909, an ultrasonic surgical aspirator system. The device is affected by a software issue that renders the touch screen unresponsive.
The recall affects 78 units distributed worldwide, including US distribution in Michigan and New York, as well as distribution to Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Poland, Spain, Switzerland, Tunisia, and the United Kingdom.
Affected units are identified by Model C7000 and specific serial numbers beginning with CH (CHA, CHB, CHC, CHD, CHE, CHF, CHG, CHH, CHJ, CHK, CHL, CHM). Healthcare providers and facilities that have received this device should contact Integra LifeSciences Corp. for guidance on remediation or replacement.
The recalled product
- Product
- CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Affected units
- 78
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model: C7000
- UDI: 10381780126232
- Serial Numbers: CHA1902101IE
- CHA2001301IE
- CHA2001401IE
- CHA2002301IE
- CHA2202301IE
- CHA2305101IE
- CHA2305401IE
- CHA2307001IE
- CHA2402201IE
- CHB1711001IE
- CHB1723601IE
- CHB2000801IE
- CHB2100901IE
- CHB2301401IE
- CHB2500101IE
- CHC1800601IE
- CHC1902601IE
- CHC1902701IE
Distribution
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