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Class 2 Device Recall CARESCAPE Patient Data Module |
 |
| Date Initiated by Firm |
May 18, 2020 |
| Date Posted |
June 24, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2424-2020 |
| Recall Event ID |
85765 |
| 510(K)Number |
K071073
|
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product |
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers:
2042084-001
2094504-001
2042084-001-046050
2042084-001-208621
2042084-001-045915
2042084-001-215164
2042084-001-078474
2042084-001-053034
2042084-001-215165
2042084-001-079462
2042084-001-047389
2042084-001-112198
2042084-001-041673
2042084-001-227238
2042084-001-071564
2042084-001-503824
2042084-001-119839
2042084-001-569269
2042084-001-041674
2042084-001-047549
2042084-001-514651
2042084-001-163572
2042084-001-583721
2042084-001-427592
2042084-001-527358
2042084-001-583723
2042084-001-317166
2042084-001-583724
2042084-001-583715
2042084-001-583718
2042084-001-055156
2042084-001-583722
2042084-001-041835
2042084-001-074124
2042084-001-583706
2042084-001-583707
2042084-001-519926
2042084-001-583717
2042084-001-583713
2042084-001-207863
2042084-001-460604
2042084-001-079192
2042084-001-197663
2042084-001-045872
2042084-001-053195
2042084-001-092010
2042084-001-560824
2042084-001-052372
2042084-001-071088
2042084-001-046667
2042084-001-213006
2042084-001-086202
2042084-001-301821
2042084-001-045720
2042084-001-060454
2042084-001-418294
2042084-001-088907
2042084-001-065769
2042084-001-589530
2042084-001-623792
2042084-001-187563
2042084-001-320333
2042084-001-357143
2042084-001-148302
To be provided
2042084-001-082825
2042084-001-057016
2042084-001-153601
2042084-001-161552
2042084-001-140229
2042084-001-611704
2042084-001-626688
2042084-001-389208
2042084-001-657836
2042084-001-225214
2042084-001-503162
2042084-001-477881
2042084-001-316025
2042084-001-046826
2042084-001-245255
2042084-001-196543
2042084-001-557725
2042084-001-505890
2042084-001-218596
2042084-001-336980
2042084-001-524525
2042084-001-600032
2042084-001-529732
2042084-001-195742
2042084-001-195782
2042084-001-573889
2042084-001-573890
2042084-001-573886
2042084-001-573887
2042084-001-195822
2042084-001-195862
2042084-001-048420
2042084-001-065538
2042084-001-055814
2042084-001-341260
2042084-001-149220
2042084-001-079193
2042084-001-229282
2042084-001-629486
2042084-001-058695
2042084-001-061170
2042084-001-629548
2042084-001-080803
2042084-001-596662
2042084-001-250146
2042084-001-202515
2042084-001-515709
2042084-001-579491
2042084-001-505608
2042084-001-065010
2042084-001-619171
|
| Code Information |
All Model Numbers that contain software versions 2.6 or 2.7 |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
| For Additional Information Contact |
GE Healthcare Service
800-437-1171
|
Manufacturer Reason
for Recall |
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
|
FDA Determined
Cause 2 |
Software Design Change |
| Action |
The firm notified its consignees by letter on 05/18/2020. The letter explained the issue, how it occurs, cautions and a workaround. The notices were disseminated to the following entities: Director of Biomedical/Clinical Engineering, Chief of Nursing, Health Care Administrator/Risk Manager. |
| Quantity in Commerce |
89,109 units |
| Distribution |
Worldwide Distribution |
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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