Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 27, 2014
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain mult…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems, Inc. recalled Philips IntelliSpace ECG Management System, with software option C61 needed to import EC… - a moderate-severity action.
Philips IntelliSpace ECG Management System, with software option C61 needed to import EC… was recalled by Philips Medical Systems, Inc. in August 27, 2014. Reason: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stres…. Check the official notice for the remedy. Verify recall #Z-2535-2014 with the FDA Devices before acting.
The recall
Philips Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stres….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- August 27, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2535-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2535-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on August 7, 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 11 units.
The documented reason for this recall is: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient id… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.. 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
11 units
Related Recalls
6
3 from same agency
Product description
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Reason for recall
Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2535-2014 |
| Date reported | August 27, 2014 |
| Date initiated | August 7, 2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 11 units |
| Distribution | Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain. |
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-2535-2014) 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? ▼
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426. Recalled by Philips Medical Systems, Inc.. Units affected: 11 units.
Why was this product recalled? ▼
Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2535-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2535-2014) 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 August 27, 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.