Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2019
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 O
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch peda…
Philips Medical Systems Nederlands recalled Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allu… - a moderate-severity action.
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allu… was recalled by Philips Medical Systems Nederlands in April 24, 2019. Reason: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequen…. Check the official notice for the remedy. Verify recall #Z-1141-2019 with the FDA Devices before acting.
The recall
Philips Medical Systems Nederlands issued this moderate-severity FDA Devices recall-Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequen….
- Moderate
- severity level
- Class II
- classification
- April 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1141-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1141-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on February 19, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems Nederlands is listed as the recalling firm, operating out of Best, N/A. Federal records list the affected scope as 7209 total.
The documented reason for this recall is: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an int… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.. 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
7209 total
Related Recalls
6
3 from same agency
Product description
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Reason for recall
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1141-2019 |
| Date reported | April 24, 2019 |
| Date initiated | February 19, 2019 |
| Recalling firm | Philips Medical Systems Nederlands |
| Firm location | Best, N/A |
| Affected scope | 7209 total |
| Distribution | US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA. |
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-1141-2019) 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 the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.. Recalled by Philips Medical Systems Nederlands. Units affected: 7209 total.
Why was this product recalled? ▼
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1141-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1141-2019) 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 24, 2019. 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.