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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94593

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

Open FDA event record

Event summary

Timeline bucket
May 02, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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 Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

Z-1926-2024
Recall number
Z-1926-2024
Initiated
May 02, 2024
Classification
Class II
Status
Ongoing
Quantity
391 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for pressure wave data synchronization from two devices may not be correct.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for pressure wave data synchronization from two devices may not be correct.

Code information

Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (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, 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1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037, , 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.

Distribution pattern

Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.