Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 8, 2020
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was…
Villa Sistemi Medicali S.p.a. recalled Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is… - a moderate-severity action.
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is… was recalled by Villa Sistemi Medicali S.p.a. in January 8, 2020. Reason: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation cha…. Check the official notice for the remedy. Verify recall #Z-0764-2020 with the FDA Devices before acting.
The recall
Villa Sistemi Medicali S.p.a. issued this moderate-severity FDA Devices recall-An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation cha….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- January 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0764-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0764-2020) was formally reported on January 8, 2020, with the manufacturer initiating the action on November 4, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Villa Sistemi Medicali S.p.a. is listed as the recalling firm, operating out of Buccinasco, N/A. Federal records list the affected scope as 3.
The documented reason for this recall is: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under s… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.. 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
3
Related Recalls
6
3 from same agency
Product description
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
Reason for recall
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0764-2020 |
| Date reported | January 8, 2020 |
| Date initiated | November 4, 2019 |
| Recalling firm | Villa Sistemi Medicali S.p.a. |
| Firm location | Buccinasco, N/A |
| Affected scope | 3 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico. |
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-0764-2020) 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? ▼
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.. Recalled by Villa Sistemi Medicali S.p.a.. Units affected: 3.
Why was this product recalled? ▼
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2020. Severity: Moderate. Recall number: Z-0764-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0764-2020) 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 January 8, 2020. 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.