Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide bra
FDA device recall Z-0266-2012 · posted 2011-11-22 · Terminated
Recall details
- Recalling firm
- Medi-Physics Inc. dba GE Healthcare
- Reason for recall
- There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
- Action taken
- 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 011-44-1494-737251 (Amersham, United Kingdom, GMT)
- Root cause
- Process control
- Status
- Terminated
- Product code
- KXK
- Quantity affected
- 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
- Date initiated
- 2011-09-20
- Date posted
- 2011-11-22
- Date terminated
- 2012-01-20
- Location
- Arlington Heights, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAPID STRAND RX (K063177) | Oncura, Inc. | 2006-11-30 |