| | Class 2 Device Recall CARESCAPE |  |
| Date Initiated by Firm | July 13, 2017 |
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| Create Date | December 06, 2017 |
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| Recall Status1 |
Terminated 3 on April 01, 2021 |
| Recall Number | Z-0202-2018 |
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| Recall Event ID |
77818 |
| 510(K)Number | K071073 |
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| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software
The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. |
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| Code Information |
Model No. 2042084-001. 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SA310455121GA, SA310518483GA, SA310518509GA, SA310528775GA, SA310528925GA, SA310539311GA, SA311142719GA, SA310528915GA, SA310260402GA, SA310455119GA, SA310528795GA, SA311090954GA, SA310260320GA, SA310260383GA, SA310300791GA, SA310300795GA, SA310300798GA, SA310300806GA, SA310341381GA, SA310361785GA, SA310382838GA, SA310392886GA, SA310393202GA, SA310434122GA, SA310507218GA, SA310518198GA, SA310518203GA, SA310518208GA, SA310518262GA, SA310518396GA, SA310518399GA, SA310518452GA, SA310518453GA, SA310518463GA, SA310518479GA, SA310518492GA, SA310518493GA, SA310518495GA, SA310518501GA, SA310518521GA, SA310518533GA, SA310528733GA, SA310528778GA, SA310528813GA, SA310528842GA, SA310528914GA, SA310528918GA, SA310528928GA, SA310528952GA, SA310528955GA, SA310528959GA, SA310528960GA, SA310529061GA, SA310529102GA, SA310539239GA, SA314409312GA, SA316420518SA, SA316420545SA, SA317030027SA, SA317040589SA, SA313127634GA, SA309466839GA, SA313430874GA, SA315482785SA, SA316025061SA, SA316025074SA, SA316025147SA, SA316025157SA, SA316035166SA, SA316035168SA, SA316035177SA, SA316035188SA, SA3xxxxxxx1GA, SA3xxxxxxx2GA, SA3xxxxxxx3GA. |
Recalling Firm/
Manufacturer |
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee WI 53223-3219
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| For Additional Information Contact | Technical Support
800-558-7044 |
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Manufacturer Reason
for Recall | Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. |
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FDA Determined
Cause 2 | Software Design Change |
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| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any questions pertaining to this recall. |
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| Quantity in Commerce | 1,196 (1,176 US; 20 OUS) |
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| Distribution | Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = MHX
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