FDA Class II Recall: GE Healthcare Carescape Central Station (CSCS) V3 MAS800… by Wipro GE Healthcare Private Ltd. — Recall Details

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Wipro GE Healthcare Private Ltd.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Wipro GE Healthcare Private Ltd. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Wipro GE Healthcare Private Ltd. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Wipro GE Healthcare Private Ltd.’s FDA history

Argus HQ has recorded 10 total FDA actions tied to Wipro GE Healthcare Private Ltd.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Wipro GE Healthcare Private Ltd.'s recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Des recalled?

FDA's recall record states the reason as: Carescape Central Station (CSCS), software version V3.0.5, 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.

Who should I contact about this recall?

Contact Wipro GE Healthcare Private Ltd. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Wipro GE Healthcare Private Ltd. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 10 total FDA actions tied to Wipro GE Healthcare Private Ltd., including 10 recalls and 0 warning letters.

Related enforcement actions

• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software v… →
• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmer… →
• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-050… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 66… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000,… →