PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
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US16230
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Invivo Corporation
Reason for Recall:
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.

Product Codes/Lot Numbers:

Model Number: 453564241901 Serial Numbers/UDI (if available): US1203010330 US1203010371 US1203010373 US1203010382 US1203010400 US1203010413 US1203010421 US1311000007 US1311000009/ (01)00884838083523(21)US1239000009 US1311000017/ (01)00884838083523(21)US1331000034 US1239000009 US1331000034 US1231000061 US1108010053 US1202010217 US1234000060 US1337000038 US1337000040 US1337000043 US1343000024 US1334000021 US1234000066 US1202010242/ (01)00884838083523(21)US1202010242 US1244000002/ (01)00884838083523(21)US1244000002 US1251000087/ (01)00884838083523(21)US1251000087 US1202010168 US1203010284 US1244000061 US1251000005 US1203010302/ (01)00884838083523(21)US1203010302 US1244000016/ (01)00884838083523(21)US1203010340 US1231000038/ (01)00884838083523(21)US1231000038 US1234000024/ (01)00884838083523(21)US1234000024 US1244000016/ (01)00884838083523(21)US1244000016 US1244000040/ (01)00884838083523(21)US1244000040 US1244000066/ (01)00884838083523(21)US1244000066 US1251000013/ 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US16230

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1867-2018

Related Recalls

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

Sep 24, 2018 Diagnostic Equipment View Details →