Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 6, 2013
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and th
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland) Inc recalled BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), … - a moderate-severity action.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), … was recalled by Philips Medical Systems (Cleveland) Inc in November 6, 2013. Reason: Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely la…. Check the official notice for the remedy. Verify recall #Z-0089-2014 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely la….
- Moderate
- severity level
- 371 units
- affected scope
- Class II
- classification
- November 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0089-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0089-2014) was formally reported on November 6, 2013, with the manufacturer initiating the action on September 3, 2013. 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 371 units.
The documented reason for this recall is: Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina,…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
371 units
Related Recalls
6
3 from same agency
Product description
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.
Reason for recall
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0089-2014 |
| Date reported | November 6, 2013 |
| Date initiated | September 3, 2013 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Cleveland, OH |
| Affected scope | 371 units |
| Distribution | Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria,… |
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-0089-2014) 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 XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 371 units.
Why was this product recalled? ▼
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0089-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0089-2014) 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.
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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 November 6, 2013. 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.