Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2013
MyRay RXDC dental unit x-ray unit
The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2…
The recall
Cefla Dental Group issued this moderate-severity FDA Devices recall — The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifi….
- Moderate
- severity level
- Class II
- classification
- May 29, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1217-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1217-2013) was formally reported on May 29, 2013, with the manufacturer initiating the action on August 10, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Cefla Dental Group is listed as the recalling firm, operating out of IMOLA, BO, N/A. Federal records list the affected scope as 173 shipped to US.
The documented reason for this recall is: The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an iden… Distribution data in the federal record shows the product reached: FOREIGN: CANADA; DOMESTIC: GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI.. 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 — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
173 shipped to US
Related Recalls
6
6 from same agency
Product description
MyRay RXDC dental unit x-ray unit
Reason for recall
The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1217-2013 |
| Date reported | May 29, 2013 |
| Date initiated | August 10, 2012 |
| Recalling firm | Cefla Dental Group |
| Firm location | IMOLA, BO, N/A |
| Affected scope | 173 shipped to US |
| Distribution | FOREIGN: CANADA; DOMESTIC: GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
MyRay RXDC dental unit x-ray unit. Recalled by Cefla Dental Group. Units affected: 173 shipped to US.
Why was this product recalled? ▼
The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2013. Severity: Moderate. Recall number: Z-1217-2013.
Where was the recalled product distributed? ▼
Distribution: FOREIGN: CANADA; DOMESTIC: GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1217-2013) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 29, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).