PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported July 31, 2019

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.

Recall #
Z-2009-2019
Affected scope
696
Initiated
June 10, 2019
Compiled from official public sources by the editorial team.
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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….

Moderate
severity level
696 units
affected scope
Class II
classification
July 31, 2019
reported

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.

Recall Insight

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.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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

Product description

BrightView SPECT, Model Number 882480

Reason for recall

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

Recall Profile

Structured summary of the FDA Devices recall record
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.

Scale of Impact

696 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2009-2019) 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.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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 SPECT, Model Number 882480. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 696.
Why was this product recalled?
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2009-2019.
Where was the recalled product distributed?
Distribution: Worldwide Distribution - US Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2009-2019) 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

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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.