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Bladder Scanner

Mianyang Meike Electronic Equipment Co., Ltd. · Model PBSV5.1 · UDI-DI 06940912715019

IYO ITX Prescription

510(k) clearances

6,553

Adverse events (17 deaths)

Recalls

351

Facilities

Description

Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.

Recalls

Date	Firm	Reason
2026-08-06	Volcano Corp	Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2022-01-24	Volcano Corp	Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique

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Data 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.