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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview DM3 Monitor

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  Class 2 Device Recall Ultraview DM3 Monitor see related information
Date Initiated by Firm June 06, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on September 18, 2012
Recall Number Z-2380-2012
Recall Event ID 62939
510(K)Number K093802  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Spacelabs Ultraview DM3 Monitor
Model Number: 91330-NT

The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Code Information Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817 
Recalling Firm/
Manufacturer		 Zoe Medical Incorporated
460 Boston St
Topsfield MA 01983-1223
For Additional Information Contact
978-887-1410
Manufacturer Reason
for Recall		 Unit fails to power up, resulting in an equipment alarm
FDA Determined
Cause 2		 Software design
Action The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.
Quantity in Commerce 35 units
Distribution Nationwide distribution: WA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = ZOE MEDICAL, INC.
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