FDA Device recall Z-1091-2016
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451 by Verathon, citing 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 M….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1091-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-30 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Verathon |
| Distribution | US |
Product
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.
Reason
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).
Identifiers
| code_info | SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7…SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A70 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Verathon
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FDA Device · Class II · 2024-06-12 · Verathon - Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
FDA Device · Class II · 2024-06-12 · Verathon - GlideScope Go Monitors
FDA Device · Class III · 2021-08-11 · Verathon - BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively
FDA Device · Class II · 2020-12-09 · Verathon - GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch…
FDA Device · Class I · 2020-07-15 · Verathon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1091-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.