Maquet Recalls VOLISTA StandOP Surgical Lights Due to Keypad Failure Risk
Maquet SAS is recalling 187 VOLISTA StandOP surgical lights because the keypads may fail. The units were distributed worldwide from October 2012 to June 2017.
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 the hazard involves a potential failure of a critical control component (keypad) in a surgical environment, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Maquet SAS is recalling 187 units of the VOLISTA StandOP (model 600) surgical lights. These devices were shipped from October 2012 until June 2017 and are equipped with specific keypads (Ref. ARD568801560). The recall is due to a potential keypad failure.
The affected surgical lights are intended to provide visible illumination of the surgical area or patient during operations, diagnostics, and treatment. The recall covers units distributed in the United States and numerous countries worldwide, including Canada, the United Kingdom, Germany, France, and Japan.
Hospitals and healthcare facilities should identify affected units by checking the serial numbers and part numbers listed in the official recall documentation. Users should contact Maquet SAS for instructions on how to proceed with the recall.
The recalled product
- Product
- VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911…
- Manufacturer
- Maquet SAS
- Hazard
- Affected units
- 187
Distribution
Distributed nationwide across the United States.
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