BladderScan Prime PLUS System

Evidence summary

The exact FDA 510(k) decision material establishes the submission identity, labeled use, inputs, population, and configuration boundary summarized here. No product-wide clinical-performance or outcome claim is promoted without an exact endpoint and version linkage.

• FDA source
• Exact FDA submission
• Checked 2026-09-04

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

1 exact-submission FDA recall record matched K172356 in the 2026-09-02 openFDA snapshot. Confirm affected model, version, units, correction, and current manufacturer instructions locally. FDA recall Z-0531-2021 is Terminated for BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.. FDA reason: Due to a change in handle material and process, probe handle may crack. FDA action: On 10/5/2020, the firm sent a "Field Defect Correction URGENT MEDICAL DEVICE RECALL" Notification to its U.S, Customers via FedEx informing them that due to an unauthorized manufacturing change, the probe handle's plastic may become brittle and crack. Customer are instructed to: 1. Review the information contained within this Recall Notice with all staff members who should be aware of the contents of the letter. 2. Check the list of Serial Numbers that are provided within the Recall Response Form. 3. Perform a visual inspection of the probe handle for cracks or damage. 4. Based on the visual inspection of your device(s), please do one of the following: a. Unboxing and Initial Use " If your BladderScan Prime Plus probe handle plastics have no visible cracks or damage and / or you do not wish for units to be serviced, complete the attached Recall Response Form by indicating no or 0 in the text box and return the form to Verathon by email to CSNotifications@verathon.com. Or " If your BladderScan Prime Plus probe handle plastics have visible cracks and you wish for these units to be serviced, complete attached Recall Response Form by indicating by number the count of probe handle plastics that require repair in the text box and return the form by email to CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. b. Subsequent Use If subsequent to submitting your Recall Response Form your BladderScan Prime Plus probes develop cracks (reference Figure 1) during subsequent use and you wish for them to be serviced, please email CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. Follow the instructions within the BladderScan Prime Plus Operations and Maintenance Manual...

• FDA source
• Exact FDA submission
• Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

• Source
• Source

• Verify deployment and data flow: The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
• Verify local validation and lifecycle monitoring: The exact FDA decision and checked recall snapshot do not establish a complete local postmarket monitoring protocol. Track version, population, anatomy, protocol, input quality, edits, failures, repeats, downstream effects, downtime, incidents, recalls, and updates locally.

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall