Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 3, 2012
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and acce
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland) Inc recalled Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMI… - a moderate-severity action.
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMI… was recalled by Philips Medical Systems (Cleveland) Inc in October 3, 2012. Reason: A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detach…. Check the official notice for the remedy. Verify recall #Z-2451-2012 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detach….
- Moderate
- severity level
- 112 units
- affected scope
- Class II
- classification
- October 3, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2451-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2451-2012) was formally reported on October 3, 2012, with the manufacturer initiating the action on August 21, 2012. 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 112 Units.
The documented reason for this recall is: A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Ital…. 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
112 Units
Related Recalls
6
3 from same agency
Product description
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Reason for recall
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2451-2012 |
| Date reported | October 3, 2012 |
| Date initiated | August 21, 2012 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Cleveland, OH |
| Affected scope | 112 Units |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Me… |
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-2451-2012) 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? ▼
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 112 Units.
Why was this product recalled? ▼
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2451-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2451-2012) 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 October 3, 2012. 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.