FDANovember 30, 2015device
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
What to do
FDA enforcement status: Terminated
Brands named
verathon
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor2024-04-29
- FDABrand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor2024-04-29
- FDAGlideScope Go Monitors2021-07-01
- FDABladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.2020-09-29
- FDAGlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endosc...2020-06-05
- FDAGlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 032019-03-31
- FDAIt is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is ad...2017-03-03
- FDAGlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-...2016-01-29
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