Z-2315-2024 Class II Ongoing
FDA device recall Z-2315-2024 was initiated by Baxter Healthcare Corporation on Jun 4, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 6243 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 17, 2024
- Initiation Date
- Jun 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6243 units
Product Description
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 Pattern
Worldwide distribution.
Code Information
All Serial Numbers: a) UDI/DI 00887761968325; b) UDI/DI 00887761968318; c) UDI/DI 00887761968301; d) UDI/DI 00887761968295; e) UDI/DI 00887761968288; f) UDI/DI 00887761968271
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2315-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026