Severity
Critical
CriticalClass IOngoing
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0929-2024) was formally reported on February 14, 2024, with the manufacturer initiating the action on December 15, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips North America is listed as the recalling firm, operating out of Cambridge, MA. Federal records list the affected scope as 302 US; 264 OUS.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Domestic distribution nationwide. International distribution worldwide.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
302 US; 264 OUS
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips North America. Units affected: 302 US; 264 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0929-2024.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution nationwide. International distribution worldwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0929-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 14, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.