Recall Z-0049-2018 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Edap Technomed Inc.
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
| Date | Aug 14, 2017 |
| Status | Terminated |
| Reason | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA. |
| Root cause | Other |
| Action | The firm, EDAP TMS, company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an " URGENT FIELD SAFETY NOTICE" letter dated 8/22/2017 delivered by email on 08/29/2016. The letter described the product, problem and actions to be taken. The customers were instructed as follows: do not use the "medium" or "low" energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols "02-medium" and "03-low". If you have any questions regarding this notification, or experience any issues with your devi |
| Quantity | 12 units |
| Distribution | US Distribution to states of: NY, FL CA, NC, TX and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153023 | Ablatherm Integrated Imaging Edap Technomed, Inc., Nov 6, 2015 |