05

Sep

2001

AGILENT TECHNOLGIES Class II

0

Company: AGILENT TECHNOLGIES
Date of Enforcement Report: 9/5/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0948-01/Z-0949-01
Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262
(B)Upgrade kits M1160A and M1170A with option LO1AnesthesiaMonitoring Systems, Models: M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with
Released C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or
M1059-81262 Upgrade kits M1160A and M1170A with option LO1

REASON:
Monitoring and alarm functions maybe temporarily disabled

MANUFACTURER:
AGILENT TECHNOLGIES (HEWLETT-PACKARD GMBH) BOEBLINGEN, BADEN-WTTBG,

RECALLED BY:
Agilent Technologies, Inc., Andover, MA., by letter on 11/7/00

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide, VA Medical Centers in CA, MO, GU,

QUANTITY:
8 devices; 152 kits

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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