Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2018
MyLab Gamma, Model 7410
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Esaote S.p.a. recalled MyLab Gamma, Model 7410 - a moderate-severity action.
MyLab Gamma, Model 7410 was recalled by Esaote S.p.a. in October 31, 2018. Reason: The probe power monitoring settings have been found to be not appropriate under specific operating condition…. Check the official notice for the remedy. Verify recall #Z-0205-2019 with the FDA Devices before acting.
The recall
Esaote S.p.a. issued this moderate-severity FDA Devices recall-The probe power monitoring settings have been found to be not appropriate under specific operating condition….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0205-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0205-2019) was formally reported on October 31, 2018, with the manufacturer initiating the action on June 11, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Esaote S.p.a. is listed as the recalling firm, operating out of Sesto Fiorentino, N/A. Federal records list the affected scope as 10.
The documented reason for this recall is: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The prob… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt …. 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 - 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 - 40,422 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
10
Related Recalls
6
0 from same agency
Product description
MyLab Gamma, Model 7410
Reason for recall
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0205-2019 |
| Date reported | October 31, 2018 |
| Date initiated | June 11, 2018 |
| Recalling firm | Esaote S.p.a. |
| Firm location | Sesto Fiorentino, N/A |
| Affected scope | 10 |
| Distribution | Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Ger… |
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-0205-2019) 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? ▼
MyLab Gamma, Model 7410. Recalled by Esaote S.p.a.. Units affected: 10.
Why was this product recalled? ▼
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0205-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0205-2019) 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.
Nearby Recalls in This Category
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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 October 31, 2018. 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.