Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call...

FDA Recall #Z-1638-2016 — Class II — December 10, 2015

Recall #Z-1638-2016 Date: December 10, 2015 Classification: Class II Status: Terminated

Product Description

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Reason for Recall

Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.

Recalling Firm

Ascom US, INC. — Morrisville, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

319

Distribution

CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.

Code Information

Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

Browse All Device Recalls Device Recall Stats Device Safety Home
Back to All Device Recalls