Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 2018
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 54
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare Japan Corporation recalled GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and v… - a moderate-severity action.
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and v… was recalled by Ge Healthcare Japan Corporation in August 29, 2018. Reason: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service…. Check the official notice for the remedy. Verify recall #Z-2872-2018 with the FDA Devices before acting.
The recall
Ge Healthcare Japan Corporation issued this moderate-severity FDA Devices recall-GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- August 29, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2872-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2872-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on April 27, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare Japan Corporation is listed as the recalling firm, operating out of Hino. Federal records list the affected scope as 4,007 devices total (products 1, 2, 3).
The documented reason for this recall is: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, …. 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
4,007 devices total (products 1, 2, 3)
Related Recalls
6
0 from same agency
Product description
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO
Reason for recall
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2872-2018 |
| Date reported | August 29, 2018 |
| Date initiated | April 27, 2018 |
| Recalling firm | Ge Healthcare Japan Corporation |
| Firm location | Hino |
| Affected scope | 4,007 devices total (products 1, 2, 3) |
| Distribution | Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, 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-2872-2018) 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? ▼
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO. Recalled by Ge Healthcare Japan Corporation. Units affected: 4,007 devices total (products 1, 2, 3).
Why was this product recalled? ▼
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2872-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, WV, WY; and countries of:: ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMEROON, Canada, CHILE, CHINA, COLOMBIA, Cote D'Ivoire, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, French Guiana, GERMANY, GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, Hong Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MALAYSIA, Mali, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW , ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, Palestine, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, REUNION, ROMANIA, Russia, RWANDA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2872-2018) 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 August 29, 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.