Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 28, 2014
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems, Inc. recalled Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The mon… - a moderate-severity action.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The mon… was recalled by Philips Medical Systems, Inc. in May 28, 2014. Reason: The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date …. Check the official notice for the remedy. Verify recall #Z-1628-2014 with the FDA Devices before acting.
The recall
Philips Medical Systems, Inc. issued this moderate-severity FDA Devices recall-The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date ….
- Moderate
- severity level
- 189K units
- affected scope
- Class II
- classification
- May 28, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1628-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1628-2014) was formally reported on May 28, 2014, with the manufacturer initiating the action on April 4, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 188,520 devices, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can c… Distribution data in the federal record shows the product reached: Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slova…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
188,520 devices
Related Recalls
6
3 from same agency
Product description
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
Reason for recall
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1628-2014 |
| Date reported | May 28, 2014 |
| Date initiated | April 4, 2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 188,520 devices |
| Distribution | Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Tur… |
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-1628-2014) 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? ▼
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.. Recalled by Philips Medical Systems, Inc.. Units affected: 188,520 devices.
Why was this product recalled? ▼
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1628-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1628-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 28, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.