Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 6, 2016
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Fa
Loss of key image functionality due to a bent pedal of the Footswitch.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems, Inc. recalled Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 70… - a moderate-severity action.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 70… was recalled by Philips Medical Systems, Inc. in April 6, 2016. Reason: Loss of key image functionality due to a bent pedal of the Footswitch.. Check the official notice for the remedy. Verify recall #Z-1279-2016 with the FDA Devices before acting.
The recall
Philips Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Loss of key image functionality due to a bent pedal of the Footswitch..
- Moderate
- severity level
- 168 units
- affected scope
- Class II
- classification
- April 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1279-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1279-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on September 24, 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 168.
The documented reason for this recall is: Loss of key image functionality due to a bent pedal of the Footswitch. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA…. 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
168
Related Recalls
6
3 from same agency
Product description
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography
Reason for recall
Loss of key image functionality due to a bent pedal of the Footswitch.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1279-2016 |
| Date reported | April 6, 2016 |
| Date initiated | September 24, 2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 168 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RI… |
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-1279-2016) 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? ▼
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recalled by Philips Medical Systems, Inc.. Units affected: 168.
Why was this product recalled? ▼
Loss of key image functionality due to a bent pedal of the Footswitch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1279-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA SOUTH KUWAIT LATVIA LEBANON LIBYA LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVIA MONGOLIA MOROCCO NEPAL NETHERLANDS NETHERLANDS ANT NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PANAMA Papua New Guinea PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUORTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERAT SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TUNISIA TURKEY UKRAINE UNITED ARAB EMI United Arab Emirates UNITED KINGDOM URUGUAY USA UZBEKISTAN VENEZUELA VIETNAM YEMEN GUADELOUPE SYRIAN ARAB REPUBLIC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1279-2016) 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 April 6, 2016. 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.