# FDA recall Z-2315-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-06-04.

## Product

iLED 7 surgical lights, Model Numbers:    a) 4068110 (Ceiling Single Surgical Light);   b) 4068120 (Mobile Surgical Light);   c) 4068140 (Pendant Surgical Light);     d) 4068210 (Ceiling Duo Surgical Lights);   e) 4068310 (Ceiling Trio Surgical Lights);   f) 4068410 (Ceiling Quad Surgical Lights)

## Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light  system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2315-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-04
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2315-2024

## Citation

> AI Analytics. FDA recall Z-2315-2024. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2315-2024. Source: US FDA. Licensed CC0.

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