| | Class 2 Device Recall Philips Interventional Hemodynamic Application |  |
| Date Initiated by Firm | May 02, 2024 |
|---|
| Date Posted | May 30, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1926-2024 |
|---|
| Recall Event ID |
94593 |
| 510(K)Number | K181311 |
|---|
| Product Classification |
Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
|
| Product | Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. |
|---|
| 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, (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, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, (01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037
(01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 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. |
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
|
| For Additional Information Contact | Virginia Huete
615-679227 Ext. 31 |
|---|
Manufacturer Reason
for Recall | Potential for pressure wave data synchronization from two devices may not be correct. |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization procedure in accordance with Section 6.9 of the IFU for the Philips Hemodynamic Application. Consignees are to complete and return the provided response form within 30 days of receipt. Customers with any questions are to contact Philips Customer Care Solutions Center at 1-800-722-9377. Philips will install a software update to correct this issue and will contact consignees to schedule the onsite visit to perform the upgrade. |
|---|
| Quantity in Commerce | 391 units |
|---|
| Distribution | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MWI
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