Severity
Moderate
FDA Devices recall · Reported July 31, 2019
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Philips Medical Systems (Cleveland) Inc recalled BrightView SPECT, Model Number 882480 - a moderate-severity action.
BrightView SPECT, Model Number 882480 was recalled by Philips Medical Systems (Cleveland) Inc in July 31, 2019. Reason: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion aft…. Check the official notice for the remedy. Verify recall #Z-2009-2019 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion aft….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2009-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2009-2019) was formally reported on July 31, 2019, with the manufacturer initiating the action on June 10, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems (Cleveland) Inc is listed as the recalling firm, operating out of Cleveland, OH. Federal records list the affected scope as 696.
The documented reason for this recall is: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide. 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.
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
696
Related Recalls
6
3 from same agency
BrightView SPECT, Model Number 882480
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2009-2019 |
| Date reported | July 31, 2019 |
| Date initiated | June 10, 2019 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Cleveland, OH |
| Affected scope | 696 |
| Distribution | Worldwide Distribution - US Nationwide |
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.
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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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 July 31, 2019. 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.