Device recall: BrightView, Gamma Camera System, Product Code 882480.
Class II FDA enforcement event 93643. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
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
Philips North America started this device recall on 30 Nov 2023. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 93643 has 3 product records. The first FDA enforcement report date is 17 Jan 2024. 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.
Domestic distribution nationwide. Foreign distribution worldwide.
Recalling firm
Philips North America, Cambridge, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0677-2024 | BrightView, Gamma Camera System, Product Code 882480. | 359 US; 328 OUS | Class II | Ongoing | 17 Jan 2024 |
| Z-0678-2024 | BrightView X, Gamma Camera, Product Code 882478 | 59 US; 59 OUS | Class II | Ongoing | 17 Jan 2024 |
| Z-0679-2024 | BrightView XCT, Gamma Camera, Product Code 882482 | 135 US; 294 OUS | Class II | Ongoing | 17 Jan 2024 |
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 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 2
- Events of the firm on the register
- 30
Other events of the firm
Official channels
- FDA enforcement report Z-0677-2024The 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.
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Cite this page
Recall Register. FDA enforcement event 93643. https://recallregister.com/fda/ii/93643/. 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:
Domestic distribution nationwide. Foreign distribution worldwide.
- What quantity of product is in FDA event 93643?
- The event has 3 product records. The first record gives this quantity:
359 US; 328 OUS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.