IBA Dosimetry GmbH: myQA iON; Article Number: MQ10-000;

Hazard

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

Details from the source

Reason for recall: Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character. Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, FL, GA, KS, MD, OK and the countries of Algeria, Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Morocco, Norway, Poland, Slovakia, Spain, Israel, Kazakhstan, Kosovo, Libya, South Africa, Turkey, United Kingdom, Switzerland, Argentina, Brazil, Mexico, APAC: Indonesia, Japan, Peoples Republic of China, Phili Quantity: 84 units (9US, 75 OUS) Lot/code info: Article Number: MQ10-000; UDI-DI: EIBAMQ010000;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.