# FDA recall Z-2502-2018

> **Maquet SAS** · Class II · device recall initiated 2018-06-14.

## Product

VOLISTA StandOP Surgical Light,   ARD568811961  VLT600DF AIM STP;  ARD568821961  VLT600DF AIM STP QL;  ARD568811911  VLT600SF AIM STP;  ARD568821911  VLT600SF AIM STP QL;  ARD568821910  VLT600SF STP QL;  ARD568811901  VLT600SF AIM STP    Product  Usage:  The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

## Reason for recall

Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.

## Distribution

Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Tanzania, Yemen, and Zimbabwe.

## Key facts

- **Recall number:** Z-2502-2018
- **Recalling firm:** Maquet SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-14
- **Report date:** 2018-07-25
- **Termination date:** 2022-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orleans, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2502-2018

## Citation

> AI Analytics. FDA recall Z-2502-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2502-2018. Source: US FDA. Licensed CC0.

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