# FDA recall Z-1349-2018

> **GETINGE US SALES LLC** · Class II · device recall initiated 2018-02-07.

## 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 surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

## Reason for recall

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. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, 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, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.

## Key facts

- **Recall number:** Z-1349-2018
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-04-18
- **Termination date:** 2021-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2018

## Citation

> AI Analytics. FDA recall Z-1349-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1349-2018. Source: US FDA. Licensed CC0.

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