BIGTIDE
Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Model HL5501SP · UDI-DI 06970438060065
DXJ
Prescription
1
510(k) clearances
525
Adverse events (15 deaths)
21
Recalls
38
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-05 | Wipro GE Healthcare Private Ltd. | 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 patien |
| 2025-09-05 | Wipro GE Healthcare Private Ltd. | 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 patien |
| 2025-05-09 | Barco N.V. | Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, vi |
| 2024-04-24 | Barco N.V. | We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDM |
| 2022-07-27 | BARCO NV | installation issues |
| 2022-05-10 | GE Healthcare, LLC | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. |
| 2022-01-28 | GE Healthcare, LLC | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. |
| 2011-07-08 | Philips Healthcare Inc. | Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventi |
| 2010-10-19 | Philips Healthcare Inc. | Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending |
| 2009-11-06 | Spacelabs Healthcare, Incorporated | Potential for monitor to shut down and not being able to power on again. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.