Z-1703-2025 Class II Ongoing
FDA device recall Z-1703-2025 was initiated by IBA Dosimetry GmbH on April 1, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 84 units (9US, 75 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- April 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units (9US, 75 OUS)
Product Description
Reason for Recall
Distribution Pattern
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, Philippines, South Korea, Thailand.