P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for c
FDA device recall Z-0027-2014 · posted 2013-10-18 · Terminated
Recall details
- Recalling firm
- SonoSite, Inc.
- Reason for recall
- FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
- Action taken
- SonoSite started calling their consignees on September 13, 2013. For customers who could not be reached via phone, a letter Urgent -Medical Device Removal will be sent on September 17, 2013. Affected customers will be offered a replacement transducer (P07698-24) free of charge. Consignees in the U.S. can call 1-877-657-8118, Monday-Friday, 6:00 a.m. - 5:00 p.m. (PST) or send E-mail to service@sonosite.com. Customers outside the US can call 425-951-1200.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
- Date initiated
- 2013-09-11
- Date posted
- 2013-10-18
- Date terminated
- 2013-12-11
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K130173) | FUJIFILM Sonosite, Inc. | 2013-03-25 |
| SONOSITE EDGE ULTRASOUND SYSTEM (K113156) | Sonosite,Inc. | 2011-11-15 |