Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 21, 2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are sel…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland) Inc recalled Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. - a moderate-severity action.
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. was recalled by Philips Medical Systems (Cleveland) Inc in September 21, 2022. Reason: When computing a radiation dose in the system, the exported dose information is incorrect when there is more …. Check the official notice for the remedy. Verify recall #Z-1744-2022 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-When computing a radiation dose in the system, the exported dose information is incorrect when there is more ….
- Moderate
- severity level
- Class II
- classification
- September 21, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1744-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1744-2022) was formally reported on September 21, 2022, with the manufacturer initiating the action on August 30, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Medical Systems (Cleveland) Inc is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 169 systems.
The documented reason for this recall is: When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen. Distribution data in the federal record shows the product reached: Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Austral…. 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
169 systems
Related Recalls
6
3 from same agency
Product description
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Reason for recall
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1744-2022 |
| Date reported | September 21, 2022 |
| Date initiated | August 30, 2022 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Gainesville, FL |
| Affected scope | 169 systems |
| Distribution | Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium… |
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-1744-2022) 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? ▼
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 169 systems.
Why was this product recalled? ▼
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1744-2022.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1744-2022) 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 September 21, 2022. 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.