Recall Z-0266-2012 ยท KXK Source, Brachytherapy, Radionuclide
Medi-Physics Inc. dba GE Healthcare
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand,
| Date | Nov 22, 2011 (initiated Sep 20, 2011) |
| Status | Terminated |
| Reason | There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy. |
| Root cause | Process control |
| Action | GE Healthcare/Oncura sent a "Urgent Medical Device Correction" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have. Please call if you have any further questions (847) 398-8400 and 011-4 |
| Quantity | 23 orders |
| Distribution | Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063177 | RAPID STRAND RX Oncura, Inc., Nov 30, 2006 |