Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained med
FDA device recall Z-1295-2015 · posted 2015-03-18 · Terminated
Recall details
- Recalling firm
- Transonic Systems Inc
- Reason for recall
- Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
- Action taken
- Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQS
- Quantity affected
- Domestic: 21 units, Foreign: 10 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
- Date initiated
- 2015-02-17
- Date posted
- 2015-03-18
- Date terminated
- 2016-05-31
- Location
- Ithaca, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) (K960817) | Transonic Systems, Inc. | 1997-02-11 |