Z-1744-2022 Class II Ongoing
FDA device recall Z-1744-2022 was initiated by Philips Medical Systems (Cleveland) Inc on August 30, 2022 and is designated Class II. Reason for recall: When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Pre… The recall status is ongoing. Affected quantity: 169 systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- August 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 systems
Product Description
Reason for Recall
Distribution Pattern
Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom.