Reported Sep 18, 2019 · Ongoing
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment…
Stryker Communications
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Communications · 571 Silveron Blvd · Flower Mound, TX · 75028
Is this the product you have?
- Berchtold Chromophare F528 Surgical Lights
- Product UsageThe medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations
- Lot codes and dates
- Serial number ranges83180-69712678 to 83180-88970377
- Amount recalled
- 946 lights
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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