Radiation-Emitting Electronic Products Corrective Actions

$79 / year

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.

Complexity

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.

Date Created

2017

Last Modified

2018-05-14

Version

2018-05-14

Update Frequency

Weekly

Temporal Coverage

2017-01 to 2018-05

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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 2017, Radiation-Emitting Electronic Products Corrective Actions and Recalls

NameDescriptionTypeConstraints
Product_NameProduct Namestringrequired : 1
Firm_NameFirm Namestringrequired : 1
Regulations_CitedRegulations linked to Corrective Action or Recallstring-
Date_PostedDate Posted.daterequired : 1
Quantity_In_CommerceConcerned quantity in commercestring-
Product_NameFirm_NameRegulations_CitedDate_PostedQuantity_In_Commerce
VeriQ SystemMedistim Asa820.9 / 870.212018-02-262
Metrotom 800Carl Zeiss Metrology Inc2018-01-2613 US
CTC laser sightsCrimson Trace Corporation2018-04-23184,390
MaquetMaquet Cardiovascular, LLC878.442017-03-144283 units
Footswitch accessoryIntegra LifeSciences Corp.2018-02-23155
GMR40NeuroLogica Corporation820.3 / 892.1682018-04-1716 units
Mobius Imaging AIRO CTBrainlab AG820.3 / 892.1752018-02-03102
CIVCO Arm SupportMed Tec Inc820.3 / 892.1832017-08-2930 units
MyLab Ultrasound SystemESAOTE S.P.A.820.3 / 892.1552018-03-201
MyLab Ultrasound SystemESAOTE S.P.A.820.3 / 892.1552018-03-205