Others titles
- FDA Radiation-Emitting Electronic Products 2020
- Radiation-Emitting Electronic Products Corrective Actions and Recalls
Keywords
- Radiation-Emitting Recalls
- FDA Recalls
- Medical Devices
- Medical Devices Recalls
- Medical Device Recalled Products
- Devices Recalls
- Radiation-Emitting Recalls
- FDA Recalls
Radiation-Emitting Electronic Products Corrective Actions
Radiation-Emitting Electronic Products Corrective Actions provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and noncompliant products from the market.
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Description
The Radiation-Emitting Electronic Products Corrective Actions and Recalls includes electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product
The Center for Devices and Radiological Health (CDRH) regulates manufacturers of radiation-emitting electronic products under the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. EPRC authorities apply to manufacturers of radiation-emitting electronic products used both in non-medical applications (e.g., laser engravers, microwave ovens, security x-ray scanners) and medical applications (e.g., ultrasound therapy, diagnostic x-ray devices, LASIK).
Corrective actions defined under EPRC are similar to Corrections and Removals defined in the medical device provisions of the FD&C Act, both of which are commonly known as “recalls.” Manufacturers are required to perform corrective actions on their electronic products when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.
When implementing corrective action, a manufacturer is required to either:
repair the products,
replace the products, or
refund the cost of the products to the purchasers (and reclaim the products) without charge to the owner of the electronic product.
About this Dataset
Data Info
Date Created | 2017 |
---|---|
Last Modified | 2022-06-06 |
Version | 2022-06-06 |
Update Frequency |
Quarterly |
Temporal Coverage |
2019-05 to 2022-06 |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Radiation-Emitting Recalls, FDA Recalls, Medical Devices, Medical Devices Recalls, Medical Device Recalled Products, Devices Recalls, Radiation-Emitting Recalls, FDA Recalls |
Other Titles | FDA Radiation-Emitting Electronic Products 2020, Radiation-Emitting Electronic Products Corrective Actions and Recalls |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Product_Name | Product Name | string | required : 1 |
Firm_Name | Firm Name | string | required : 1 |
Regulations_Cited | Regulations linked to Corrective Action or Recall | string | - |
Date_Posted | Date Posted. | date | required : 1 |
Quantity_In_Commerce | Concerned quantity in commerce | string | - |
Data Preview
Product Name | Firm Name | Regulations Cited | Date Posted | Quantity In Commerce |
CoolSeal Generator | Bolder Surgical, LLC | 820.7/878.44 | 2022-03-08 | 10 |
CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 807.81/886.157 | 2022-03-04 | 1,272 devices |
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated | Covidien Llc | 820.7/878.44 | 2022-01-13 | 504 devices |
4 Series Phototherapy Unit | Daavlin Distributing Company | 878.463 | 2022-05-12 | 1 |
1 Series Phototherapy Unit | Daavlin Distributing Company | 878.463 | 2022-05-12 | 216 |
E-Guard PCA 4000 Curing Units | Envisiontec US Llc | 820.8/872.607 | 2022-03-10 | 172 units |
Revolution Apex, Revolution CT | GE Healthcare, LLC | 1003.2/892.175 | 2022-04-05 | 273 (51 US; 222 OUS) in total |
GE Healthcare SIGNA 3.0T with Excite | GE Healthcare, LLC | 820.7/892.1 | 2022-02-09 | 17,228 devices total in this field correction |
GE Healthcare SIGNA Horizon Cx | GE Healthcare, LLC | 820.7/892.1 | 2022-02-09 | 17,228 devices total in this field correction |
GE Healthcare SIGNA OpenSpeed | GE Healthcare, LLC | 820.7/892.1 | 2022-02-09 | 17,228 devices total in this field correction |