| | Class 2 Device Recall uCT ATLAS Astound |  |
| Date Initiated by Firm | August 11, 2026 |
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| Date Posted | September 25, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3282-2026 |
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| Recall Event ID |
99731 |
| 510(K)Number | K203448 K231482 K243617 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | Computed Tomography X-ray System, Model: uCT ATLAS Astound with software |
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| Code Information |
UDI-DI: 06971576831340.
Serial Number/Software:
803011/R002.9.0.1897081-Re3310SP1,
803012/R002.4.6.1607336-Re3100SP4,
803013/R002.4.6.1607336-Re3100SP4,
803014/R002.9.0.1897081-Re3310SP1,
803016/R002.4.6.1607336-Re3100SP4,
803017/R002.9.0.1897081-Re3310SP1,
803018/R002.9.0.1897081-Re3310SP1,
803019/R002.4.6.1607336-Re3100SP4,
803020/R002.9.0.1897081-Re3310SP1,
803022/R002.9.0.1897081-Re3310SP1,
803023/R002.9.0.1897081-Re3310SP1,
803024/R002.9.0.1897081-Re3310SP1,
809001/R002.8.1.1840891-Re3310A_P1,
809002/R002.9.0.1897081-Re3310SP1,
809003/R002.8.1.1840891-Re3310A_P1,
809004/R002.4.6.1607336-Re3100SP4,
809005/R002.4.6.1607336-Re3100SP4,
809006/R002.8.1.1840891-Re3310A_P1,
809007/R002.4.7.1671762-Re3100SP4_P1,
809008/R002.4.7.1671762-Re3100SP4_P1,
809009/R002.4.7.1671762-Re3100SP4_P1,
809010/R002.4.7.1671762-Re3100SP4_P1,
809011/R002.4.7.1671762-Re3100SP4_P1,
809012/R002.4.7.1671762-Re3100SP4_P1,
809013/R002.4.7.1671762-Re3100SP4_P1,
809014/R002.7.4.1810621-Re3300SP1H1_P3,
809015/R002.7.4.1810621-Re3300SP1H1_P3,
809016/R002.9.0.1897081-Re3310SP1,
809017/R002.9.0.1897081-Re3310SP1,
809018/R002.7.4.1810621-Re3300SP1H1_P3,
809019/R002.7.4.1810621-Re3300SP1H1_P3,
809020/R002.9.0.1897081-Re3310SP1,
809021/R002.7.4.1810621-Re3300SP1H1_P3,
809022/R002.7.4.1810621-Re3300SP1H1_P3,
809023/R002.7.4.1810621-Re3300SP1H1_P3,
809024/R002.7.4.1810621-Re3300SP1H1_P3,
809025/R002.7.4.1810621-Re3300SP1H1_P3,
809026/R002.7.4.1810621-Re3300SP1H1_P3,
809027/R002.7.4.1810621-Re3300SP1H1_P3,
809028/R002.9.0.1897081-Re3310SP1,
809029/R002.7.4.1810621-Re3300SP1H1_P3,
809030/R002.7.4.1810621-Re3300SP1H1_P3,
809031/R002.7.4.1810621-Re3300SP1H1_P3,
809032/R002.7.4.1810621-Re3300SP1H1_P3,
809033/R002.9.0.1897081-Re3310SP1,
809034/R002.9.0.1897081-Re3310SP1,
809035/R002.9.0.1897081-Re3310SP1,
809036/R002.9.0.1897081-Re3310SP1,
809037/R002.9.0.1897081-Re3310SP1,
809038/R002.9.0.1897081-Re3310SP1,
809039/R002.9.0.1897081-Re3310SP1,
809040/R002.9.0.1897081-Re3310SP1,
809041/R002.9.0.1897081-Re3310SP1
|
| FEI Number |
3011015597
|
Recalling Firm/
Manufacturer |
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai
China
|
Manufacturer Reason
for Recall | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans. |
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FDA Determined
Cause 2 | Software design |
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| Action | On 8/11/2026, correction notices were emailed to customers informing them that software will be released to resolve the software problem. Customers were asked to do the following:
When using the Study Split function, follow the requirements below:
1) Temporarily disable the "Study Split" function. Navigate to the system configuration interface and uncheck the "Auto Study Split" option.
2) If the "Study Split" function is clinically necessary, open the system configuration interface and select "Split on PACS" instead of "Split on Local".
3) When "Auto study split" is checked, ensure that PACS (Picture Archiving and Communication System) is configured on site and auto-archive is enabled.
4) If images are found to be missing on the PA interface, immediately verify whether the corresponding image data exists in the PACS.
a) If images exist in PACS: They can be retrieved from PACS for review.
b) If images do not exist in PACS: Contact the firm's service engineer for assistance.
For further questions, contact firm service engineer or call firm Customer Contact Center at (855) 221-1552 or 832-699-2799 |
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| Quantity in Commerce | 53 |
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| Distribution | US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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