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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87732

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 29, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex Cardio FC2010 Rev C 453564621791 Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021 Xper Flex Cardio 2010 Rev D 453564669081 Xper Flex Cardio 2010 Rev D Russia 453564674581 Xper Flex Cardio FC2010 Rev E 453564845841 Xper Flex Cardio 2010 Rev E Russia 453564845881 Service numbers associated with FC2020: Xper Flex Cardio 2020 Rev A 453564241911 Xper Flex Cardio 2020 Rev B 453564483331 Flex Cardio FC2020 Rev C 453564621801 Xper Flex Cardio 2020 Rev D 453564675001 Xper Flex Cardio FC2020 Rev E 453564845861 Software version number: 1.5.19 and 1.6.8

Z-1517-2021
Recall number
Z-1517-2021
Initiated
March 29, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
9208 units WW

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software used with the Xper Flex Cardio Physio Monitoring System may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor

Code information

Service Number/ UDI # 453564241901 (01)00884838082113; 453564241911 (01)00884838082113; 453564483321 (01)00884838082113; 453564483331 (01)00884838083516; 453564621791 (01)00884838084902; 453564621801 (01)00884838084919; 453564845881 (01)00884838095052; 453564675021 (01)00884838103245; 453564669081 (01)00884838083820; 453564675001 (01)00884838086005; 453564674581 (01)00884838083820; 453564845841 (01)00884838093645; 453564845861 (01)00884838093652

Distribution pattern

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