Recall Z-1217-2013— CEFLA DENTAL GROUP
Class II · Terminated
Class II FDA medical device recall by CEFLA DENTAL GROUP, initiated 2012-08-10, terminated 2015-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: MyRay RXDC dental unit x-ray unit. Reason: 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.
- Recalling firm
- CEFLA DENTAL GROUP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-10
- Terminated
- 2015-03-04
- Firm location
- IMOLA, BO, N/A, Italy
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.