FDA Devices recall · Reported March 21, 2018
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AE
Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of informatio…
Philips Electronics North America Corporation recalled HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospi… - a low-severity action.
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospi… was recalled by Philips Electronics North America Corporation in March 21, 2018. Reason: Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event log…. Check the official notice for the remedy. Verify recall #Z-0978-2018 with the FDA Devices before acting.
The recall
Philips Electronics North America Corporation issued this low-severity FDA Devices recall-Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event log….
- Low
- severity level
- 4K units
- affected scope
- Class III
- classification
- March 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0978-2018 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
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
Reason for recall
Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0978-2018 |
| Date reported | March 21, 2018 |
| Date initiated | February 7, 2018 |
| Recalling firm | Philips Electronics North America Corporation |
| Firm location | Andover, MA |
| Affected scope | 4315 |
| Distribution | Foreign Only - China |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0978-2018) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026