Reported Jun 5, 2024 · Ongoing
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
- Lot codes and dates
Software Versions 1.2.01.2.11.2.21.2.31.3.01.3.1. Model No. 722467
- UDI
365 of 365 codes
(01)00884838100084 (11)200826(10)5.2.0.0(01)00884838101180(21)616(01)00884838101180(21)349(01)00884838101180(21)2111600488(01)00884838101180(21)2111601116(01)00884838101180(21)482(01)00884838101180(21)412(01)00884838101180(21)2111601659(01)00884838101180(21)2111601041(01)00884838101180(21)2111601582(01)00884838101180(21)251(01)00884838101180(21)934(01)00884838101180(21)305(01)00884838101180(21)295(01)00884838101180(21)2111600498(01)00884838101180(21)217(01)00884838101180(21)527(01)00884838101180(21)2111600927(01)00884838101180(21)247(01)00884838101180(21)431(01)00884838101180(21)2111601322(01)00884838101180(21)2111600711(01)00884838101180(21)455(01)00884838101180(21)256(01)00884838101180(21)268(01)00884838101180(21)744(01)00884838101180(21)795(01)00884838101180(21)800(01)00884838101180(21)64(01)00884838101180(21)2111601489(01)00884838101180(21)685(01)00884838101180(21)2111600884(01)00884838101180(21)2111600887(01)00884838101180(21)629(01)00884838101180(21)2111600641(01)00884838101180(21)2111601079(01)00884838101180(21)2111601443(01)00884838101180(21)2111601444(01)00884838101180(21)1104(01)00884838101180(21)1133(01)00884838101180(21)812(01)00884838101180(21)2111601067(01)00884838101180(21)571(01)00884838101180(21)2111600465(01)00884838101180(21)2111600628(01)00884838101180(21)2111600809(01)00884838101180(21)1195(01)00884838101180(21)2111601172(01)00884838101180(21)2111601176(01)00884838101180(21)168(01)00884838101180(21)2111600797(01)00884838101180(21)2111600664(01)00884838101180(21)195(01)00884838101180(21)196(01)00884838101180(21)780(01)00884838101180(21)781(01)00884838101180(21)69(01)00884838101180(21)2111600764(01)00884838101180(21)2111601312(01)00884838101180(21)2111600814
- Serial No
390 of 390 codes
CZC9509HWCCZC950919KCZC9509HTZCZC112CW4W3203616MXL2342FBKMXL2342F9NMXL2342F9DMXL221294QMXL221294ZCZC12095LJCZC12175YYMXL221293RMXL221293YMXL2342F16MXL2342FOCMXL2342FB4MXL2342FB9MXL2342F9KCZC1088DDMCZC1099NF4MXL3362KYBCZC1077045CZC107704MCZC1077043CZC107705D349211160048821116011164824122111601659211160104121116015822519343052952111600498217527211160092724743121116013222111600711455256268744795800642111601489685211160088421116008876292111600641
- Amount recalled
- 391 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for pressure wave data synchronization from two devices may not be correct.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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