Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 18, 2015
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
There is a potential for unintended and erratic motion.
Virtual Imaging, Inc. recalled Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. - a moderate-severity action.
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. was recalled by Virtual Imaging, Inc. in February 18, 2015. Reason: There is a potential for unintended and erratic motion.. Check the official notice for the remedy. Verify recall #Z-1064-2015 with the FDA Devices before acting.
The recall
Virtual Imaging, Inc. issued this moderate-severity FDA Devices recall-There is a potential for unintended and erratic motion..
- Moderate
- severity level
- Class II
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1064-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1064-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on September 22, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Virtual Imaging, Inc. is listed as the recalling firm, operating out of Boca Raton, FL. Federal records list the affected scope as 316 (US) 6 (Foreign).
The documented reason for this recall is: There is a potential for unintended and erratic motion. Distribution data in the federal record shows the product reached: USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in So…. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
316 (US) 6 (Foreign)
Related Recalls
6
6 from same agency
Product description
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
Reason for recall
There is a potential for unintended and erratic motion.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1064-2015 |
| Date reported | February 18, 2015 |
| Date initiated | September 22, 2014 |
| Recalling firm | Virtual Imaging, Inc. |
| Firm location | Boca Raton, FL |
| Affected scope | 316 (US) 6 (Foreign) |
| Distribution | USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the c… |
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-1064-2015) 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? ▼
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.. Recalled by Virtual Imaging, Inc.. Units affected: 316 (US) 6 (Foreign).
Why was this product recalled? ▼
There is a potential for unintended and erratic motion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1064-2015.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1064-2015) 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 February 18, 2015. 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 August 2026.