PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported July 1, 2020

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 2042084-0

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 moni…

Recall #
Z-2424-2020
Affected scope
89,109 units
Initiated
May 18, 2020
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Ge Healthcare, LLC recalled CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650… - a moderate-severity action.

CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650… was recalled by Ge Healthcare, LLC in July 1, 2020. Reason: The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR …. Check the official notice for the remedy. Verify recall #Z-2424-2020 with the FDA Devices before acting.

The recall

Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR ….

Moderate
severity level
89K units
affected scope
Class II
classification
July 1, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2424-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-2424-2020
Date reported July 1, 2020
Date initiated May 18, 2020
Recalling firm Ge Healthcare, LLC
Firm location Waukesha, WI
Affected scope 89,109 units
Distribution Worldwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

89,109 units units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2424-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Ge Healthcare, LLC. Units affected: 89,109 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2424-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Methodology · Corrections · Archive as of August 2026