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

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.

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.