Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 1, 2017
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adapt
Power outages causes reporting software to shutdown.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tosoh Smd Inc recalled Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software i… - a moderate-severity action.
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software i… was recalled by Tosoh Smd Inc in March 1, 2017. Reason: Power outages causes reporting software to shutdown.. Check the official notice for the remedy. Verify recall #Z-1245-2017 with the FDA Devices before acting.
The recall
Tosoh Smd Inc issued this moderate-severity FDA Devices recall-Power outages causes reporting software to shutdown..
- Moderate
- severity level
- 34 units
- affected scope
- Class II
- classification
- March 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1245-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1245-2017) was formally reported on March 1, 2017, with the manufacturer initiating the action on December 22, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Tosoh Smd Inc is listed as the recalling firm, operating out of Grove City, OH. Federal records list the affected scope as 34.
The documented reason for this recall is: Power outages causes reporting software to shutdown. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.. 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
34
Related Recalls
6
3 from same agency
Product description
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.
Reason for recall
Power outages causes reporting software to shutdown.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1245-2017 |
| Date reported | March 1, 2017 |
| Date initiated | December 22, 2016 |
| Recalling firm | Tosoh Smd Inc |
| Firm location | Grove City, OH |
| Affected scope | 34 |
| Distribution | US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV. |
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-1245-2017) 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? ▼
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.. Recalled by Tosoh Smd Inc. Units affected: 34.
Why was this product recalled? ▼
Power outages causes reporting software to shutdown.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1245-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1245-2017) 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 1, 2017. 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.