FDA Devices recall · Reported February 14, 2024
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or f…
Philips North America recalled BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit forma… - a critical-severity action.
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit forma… was recalled by Philips North America in February 14, 2024. Reason: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gant…. Check the official notice for the remedy. Verify recall #Z-0929-2024 with the FDA Devices before acting.
The recall
Philips North America issued this critical-severity FDA Devices recall-Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gant….
- Critical
- severity level
- Class I
- classification
- February 14, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0929-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
Reason for recall
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0929-2024 |
| Date reported | February 14, 2024 |
| Date initiated | December 15, 2023 |
| Recalling firm | Philips North America |
| Firm location | Cambridge, MA |
| Affected scope | 302 US; 264 OUS |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0929-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026