Getinge Recalls VOLISTA StandOP Surgical Lights Due to Handle Detachment Risk
Getinge is recalling 5,214 VOLISTA StandOP surgical lights because the central handle holder can detach, potentially dropping particles into the sterile field 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 the hazard involves a risk of harm (contamination of the sterile field) where specific injury or illness has not yet been reported, fitting the High severity criteria.
Plain-English summary
Getinge US Sales LLC is recalling 5,214 units of the VOLISTA StandOP Surgical Light, including models VLT600 SF AIM STP and VLT600 DF AIM STP. The devices are designed to illuminate patients during surgical operations, diagnostics, and treatment, and are installed in surgical suites, examining rooms, and outpatient consultations.
The recall was initiated after the manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. If this detachment occurs, particles from the handle holder ring could fall into the sterile field during a procedure.
The affected units were distributed nationwide in the United States and in numerous countries worldwide. Healthcare facilities should stop using the affected devices and contact Getinge US Sales LLC for instructions on the corrective action.
The recalled product
- Product
- VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These…
- Manufacturer
- GETINGE US SALES LLC
- Affected units
- 5,214
Distribution
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