PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported June 4, 2014

LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low ba…

Recall #
Z-1660-2014
Affected scope
96,611 units total (40,974 in the US and 55,637 outside the US)
Initiated
May 9, 2014
Verify with FDA Devices →
View my saved recalls

Physio-Control, Inc. recalled LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mo… - a moderate-severity action.

LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mo… was recalled by Physio-Control, Inc. in June 4, 2014. Reason: Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibr…. Check the official notice for the remedy. Verify recall #Z-1660-2014 with the FDA Devices before acting.

The recall

Physio-Control, Inc. issued this moderate-severity FDA Devices recall-Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibr….

Moderate
severity level
97K units
affected scope
Class II
classification
June 4, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1660-2014 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

LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

Reason for recall

Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100

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 Terminated
Recall number Z-1660-2014
Date reported June 4, 2014
Date initiated May 9, 2014
Recalling firm Physio-Control, Inc.
Firm location Redmond, WA
Affected scope 96,611 units total (40,974 in the US and 55,637 outside the US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLAN…

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

Scale of Impact

96,611 units total (40,974 in the US and 55,637 outside the US) 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-1660-2014) 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?
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.. Recalled by Physio-Control, Inc.. Units affected: 96,611 units total (40,974 in the US and 55,637 outside the US).
Why was this product recalled?
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100
Which agency issued this recall?
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1660-2014.
Where was the recalled product distributed?
Distribution: Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, Espa¿a, FAROE ISLANDS, FINLAND, FRANCE, FRENCH GUIANA, FRENCH POLYNESIA, GABON, GEORGIA, GERMANY, GREECE, GUAM, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF, IRAQ, IRELAND, ISRAEL, ITALY, Japan, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACAU, MACEDONIA, THE FORMER YUGOSL, MALAYSIA, MALDIVES, MALTA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA FEDERATION, SAN MARINO, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, Suriname, South America, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA..
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported June 4, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026