Device recall: Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment…
Class II FDA enforcement event 83355. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this device recall on 22 Mar 2019. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Flower Mound, TX. FDA put the recall in Class II. FDA event 83355 has 2 product records. The first FDA enforcement report date is 18 Sep 2019. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution was nationwide, including to Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada,…
Recalling firm
The name is withheld, Flower Mound, TX.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2539-2019 | Berchtold Chromophare F528 Surgical Lights. Product Usage: The 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… | 946 lights | Class II | Ongoing | 18 Sep 2019 |
| Z-2540-2019 | Berchtold Chromophare F628 Surgical Lights. Product Usage: The 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… | 3,344 lights | Class II | Ongoing | 18 Sep 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 2
Official channels
- FDA enforcement report Z-2539-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83355. https://recallregister.com/fda/ii/83355/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution was nationwide, including to Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada,…
- What quantity of product is in FDA event 83355?
- The event has 2 product records. The first record gives this quantity:
946 lights
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.