Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 25, 2015
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
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 disp…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Transonic Systems Inc recalled Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Moni… - a moderate-severity action.
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Moni… was recalled by Transonic Systems Inc in March 25, 2015. Reason: Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during d…. Check the official notice for the remedy. Verify recall #Z-1295-2015 with the FDA Devices before acting.
The recall
Transonic Systems Inc issued this moderate-severity FDA Devices recall-Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during d….
- Moderate
- severity level
- Class II
- classification
- March 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1295-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1295-2015) was formally reported on March 25, 2015, with the manufacturer initiating the action on February 17, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Transonic Systems Inc is listed as the recalling firm, operating out of Ithaca, NY. Federal records list the affected scope as Domestic: 21 units, Foreign: 10 units.
The documented reason for this recall is: 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 pro… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Domestic: 21 units, Foreign: 10 units
Related Recalls
6
3 from same agency
Product description
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1295-2015 |
| Date reported | March 25, 2015 |
| Date initiated | February 17, 2015 |
| Recalling firm | Transonic Systems Inc |
| Firm location | Ithaca, NY |
| Affected scope | Domestic: 21 units, Foreign: 10 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1295-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.. Recalled by Transonic Systems Inc. Units affected: Domestic: 21 units, Foreign: 10 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1295-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1295-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.