ModerateClass IIOngoing

FDA Devices recall · Reported July 2, 2025

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Mode

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 2, 2025. Severity: Moderate. Recall number: Z-2030-2025.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2030-2025) 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.

Q: 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.

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previo…

Recall #: Z-2030-2025
Affected scope: 792 units
Initiated: May 16, 2025

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

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Ge Medical Systems China Co., Ltd. recalled GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalo… — a moderate-severity action.

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalo… was recalled by Ge Medical Systems China Co., Ltd. in July 2, 2025. Reason: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana …. Check the official notice for the remedy. Verify recall #Z-2030-2025 with the FDA Devices before acting.

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The recall

Ge Medical Systems China Co., Ltd. issued this moderate-severity FDA Devices recall — GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana ….

Moderate
severity level: 792 units
affected scope: Class II
classification: July 2, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2030-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2030-2025) was formally reported on July 2, 2025, with the manufacturer initiating the action on May 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Medical Systems China Co., Ltd. is listed as the recalling firm, operating out of Wuxi. Federal records list the affected scope as 792 units.

The documented reason for this recall is: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz … Distribution data in the federal record shows the product reached: Worldwide distribution.. 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, 6 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.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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.

Severity

Moderate

Affected scope

792 units

Related Recalls

6 from same agency

Product description

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

Reason for recall

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2030-2025
Date reported	July 2, 2025
Date initiated	May 16, 2025
Recalling firm	Ge Medical Systems China Co., Ltd.
Firm location	Wuxi
Affected scope	792 units
Distribution	Worldwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

792 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2030-2025) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 2, 2025. Severity: Moderate. Recall number: Z-2030-2025.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2030-2025) 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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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 2, 2025.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.