Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 25, 2017
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the result…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carestream Health Inc recalled Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultraso… - a moderate-severity action.
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultraso… was recalled by Carestream Health Inc in January 25, 2017. Reason: Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a m…. Check the official notice for the remedy. Verify recall #Z-1052-2017 with the FDA Devices before acting.
The recall
Carestream Health Inc issued this moderate-severity FDA Devices recall-Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a m….
- Moderate
- severity level
- Class II
- classification
- January 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1052-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1052-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on November 21, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Carestream Health Inc is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as US: 14 units; Foreign: 16 units.
The documented reason for this recall is: Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia. 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
US: 14 units; Foreign: 16 units
Related Recalls
6
3 from same agency
Product description
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
Reason for recall
Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1052-2017 |
| Date reported | January 25, 2017 |
| Date initiated | November 21, 2016 |
| Recalling firm | Carestream Health Inc |
| Firm location | Rochester, NY |
| Affected scope | US: 14 units; Foreign: 16 units |
| Distribution | Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia |
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-1052-2017) 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? ▼
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body. Recalled by Carestream Health Inc. Units affected: US: 14 units; Foreign: 16 units.
Why was this product recalled? ▼
Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1052-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1052-2017) 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 January 25, 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.