| | Class 2 Device Recall GE Healthcare Carescape |  |
| Date Initiated by Firm | September 05, 2025 |
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| Date Posted | October 21, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0213-2026 |
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| Recall Event ID |
97646 |
| 510(K)Number | K162012 |
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| Product Classification |
Display, cathode-ray tube, medical - Product Code DXJ
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| Product | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube |
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| Code Information |
GTIN 00195278343512, Serial Numbers: STU25210418SA, STU25210417SA, STU25210419SA, STU25250440SA, STU25250439SA, STU25260447SA, STU25210407SA, STU25210406SA, STU24200003SA, STU24200006SA, STU24200005SA, STU24200004SA, STU23240015SA, STU24240019SA, STU24240020SA, STU24240007SA, STU24240022SA, STU24240021SA, STU24330020SA, STU24240014SA, STU24240013SA, STU24330019SA, STU24330022SA, STU24330016SA, STU24240005SA, STU24240008SA, STU24240012SA, STU24330018SA, STU24330021SA, STU24330017SA, STU23160011SA, STU23240007SA, STU24310001SA, STU25210433SA, STU25210432SA, STU25200390SA, STU25200392SA, STU25200391SA, STU25200399SA, STU25200397SA, STU25200395SA, STU25200393SA, STU25200398SA, STU25200396SA, STU25250438SA, STU25270475SA, STU25270456SA, STU25270468SA, STU25270458SA, STU25270466SA, STU25270476SA, STU25270469SA, STU25270473SA, STU25270459SA, STU25270474SA, STU25270467SA, STU25210430SA, STU25210429SA, STU25180343SA, STU25190347SA, STU25190348SA, STU24200007SA, STU25190360SA, STU25240436SA, STU25190361SA, STU25190362SA, STU25190363SA, STU25240437SA, STU25190359SA, STU24510027SA, STU24510032SA, STU24510010SA, STU24510020SA, STU24510017SA, STU24510026SA, STU24510018SA, STU24510024SA, STU24510025SA, STU24510031SA, STU24510011SA, STU24510029SA, STU24510023SA, STU24510030SA, STU24510021SA, STU24510019SA, STU24510022SA, STU25190350SA, STU25200388SA, STU25200389SA, STU25210412SA, STU25190349SA, STU25190381SA, STU25190376SA, STU25190383SA, STU25190374SA, STU25190367SA, STU25190372SA, STU25190379SA, STU25190368SA, STU25190352SA, STU25190358SA, STU25190370SA, STU25190366SA, STU25190355SA, STU25190354SA, STU25190382SA, STU25190380SA, STU25190371SA, STU25190377SA, STU25190353SA, STU25190351SA, STU25190364SA, STU25190357SA, STU25190384SA, STU25190369SA, STU25190373SA, STU25190356SA, STU25190365SA, STU25190378SA, STU25190385SA, STU25210410SA, STU25210411SA, STU25210409SA, STU25230435SA, STU25180346SA, STU25180344SA, STU25180345SA, STU25210413SA, STU25210414SA, STU25210423SA, STU25210431SA, STU25210415SA, STU25270453SA, STU25260450SA, STU25260451SA, STU25290488SA, STU25210408SA, STU25210400SA, STU25270454SA, STU25210404SA, STU25210421SA, STU25270464SA, STU25210420SA, STU25270462SA, STU25210425SA, STU25270461SA, STU25210426SA, STU25210428SA, STU25210427SA, STU25270463SA, STU25270460SA, STU24460058SA, STU24460059SA, STU24460071SA, STU24460060SA, STU25200387SA, STU25210401SA, STU25200386SA, STU25210424SA, STU25270457SA, STU25270465SA, STU25300492SA, STU25210402SA, STU25210403SA, STU25250446SA, STU25210422SA, STU25210405SA, STU25260449SA, STU25290481SA, STU25290482SA, STU25290483SA, STU25290484SA, STU25210416SA. |
Recalling Firm/
Manufacturer |
Wipro GE Healthcare Private Ltd.
122 Part 1
Odyssey And Galileo
Bengaluru India
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer Reason
for Recall | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. |
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FDA Determined
Cause 2 | Software design |
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| Action | GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/05/2025, by letter delivered via traceable means. The notice explained the issues and requested the following:
"Actions to be taken by Customer/User
Pending correction by GE HealthCare, you can continue to use your device by following the instructions below.
1. Determine the number of central stations that are connected to the network including those in any offsite Central Monitoring Unit.
2. Ensure the number of connected central stations are fewer than 118 or more than 120.
If you need assistance completing steps 1 or 2, please contact GE HealthCare Service or your local Service Representative.
Note: Any versions prior to CSCS V3.0.5 are not affected by this issue.
Ensure all users are aware of, understand, and follow these instructions.
Please retain this document for your records.
GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction.
If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 173 units |
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| Distribution | Worldwide distribution. |
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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 = DXJ
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