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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93966

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 06, 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

3 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 3

Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280

Z-1176-2024
Recall number
Z-1176-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

Code information

OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3)Model: 722280 20 (01)00884838103276(21)20

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

device · product 2 of 3

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

Z-1177-2024
Recall number
Z-1177-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

Code information

OUS (1) Model: 722227 SN: UDI: 75 (01)00884838099227(21)75 122 (01)00884838099227(21)122 131 (01)00884838099227(21)131 132 (01)00884838099227(21)132 165 (01)00884838099227(21)165 116 (01)00884838099227(21)116 136 (01)00884838099227(21)136.' (2) Model: 722228 Serial Number UDI 168 (01)00884838099234(21)168 197 (01)00884838099234(21)197 154 (01)00884838099234(21)154 193 (01)00884838099234(21)193 165 (01)00884838099234(21)165 163 (01)00884838099234(21)163 139 (01)00884838099234(21)139 202 (01)00884838099234(21)202 141 (01)00884838099234(21)141 200 (01)00884838099234(21)200 174 (01)00884838099234(21)174 178 (01)00884838099234(21)178 147 (01)00884838099234(21)147 208 (01)00884838099234(21)208 171 (01)00884838099234(21)171 167 (01)00884838099234(21)167 194 (01)00884838099234(21)194 176 (01)00884838099234(21)176 228 (01)00884838086777(10)2.0.0.10015 161 (01)00884838099234(21)161

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

device · product 3 of 3

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

Z-1178-2024
Recall number
Z-1178-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
10 units US; 124 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

Code information

US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974 905 (01)00884838099258(21)905 (3) Model: 722225 227 (01)00884838099265(21)227 (4) Model: 722226 441 (01)00884838099272(21)441 398 (01)00884838099272(21)398 OUS: 179 (01)00884838099265(21)179 145 (01)00884838099265(21)145 223 (01)00884838099265(21)223 226 (01)00884838099265(21)226 232 (01)00884838099265(21)232 196 (01)00884838099265(21)196 159 (01)00884838099265(21)159 200 (01)00884838099265(21)200 234 (01)00884838099265(21)234 206 (01)00884838099265(21)206. 412 (01)00884838099272(21)412 425 (01)00884838099272(21)425 420 (01)00884838099272(21)420 355 (01)00884838099272(21)355 393 (01)00884838099272(21)393 407 (01)00884838099272(21)407 402 (01)00884838099272(21)402 527 (01)00884838099272(21)527 479 (01)00884838099272(21)479 509 (01)00884838099272(21)509 460 (01)00884838099272(21)460 505 (01)00884838099272(21)505 513 (01)00884838099272(21)513 485 (01)00884838099272(21)485 364 (01)00884838099272(21)364 507 (01)00884838099272(21)507 577 (01)00884838099272(21)577 476 (01)00884838099272(21)476 515 (01)00884838099272(21)515 596 (01)00884838099272(21)596 598 (01)00884838099272(21)598 521 (01)00884838099272(21)521 455 (01)00884838099272(21)455 589 (01)00884838099272(21)589 575 (01)00884838099272(21)575 522 (01)00884838099272(21)522 540 (01)00884838099272(21)540. 506 (01)00884838099241(21)506 550 (01)00884838099241(21)550 613 (01)00884838099241(21)613 121 (01)00884838099241(21)121 630 (01)00884838099241(21)630 474 (01)00884838099241(21)474 614 (01)00884838099241(21)614 612 (01)00884838099241(21)612 523 (01)00884838099241(21)523 517 (01)00884838099241(21)517 554 (01)00884838099241(21)554 450 (01)00884838099241(21)450 542 (01)00884838099241(21)542 623 (01)00884838099241(21)623 475 (01)00884838099241(21)475 547 (01)00884838099241(21)547 397 (01)00884838099241(21)397 586 (01)00884838099241(21)586 42 (01)00884838099241(21)42 492 (01)00884838099241(21)492 427 (01)00884838099241(21)427 520 (01)00884838099241(21)520 708 (01)00884838099241(21)708 524 (01)00884838099241(21)524 497 (01)00884838099241(21)497 519 (01)00884838099241(21)519 394 (01)00884838099241(21)394 600 (01)00884838099241(21)600. 1154 (01)00884838099258(21)1154 1438 (01)00884838099258(21)1438 1351 (01)00884838099258(21)1351 1139 (01)00884838099258(21)1139 1326 (01)00884838099258(21)1326 1391 (01)00884838099258(21)1391 1075 (01)00884838099258(21)1075 1281 (01)00884838099258(21)1281 1497 (01)00884838099258(21)1497 802 (01)00884838099258(21)802 1553 (01)00884838099258(21)1553 1401 (01)00884838099258(21)1401 1348 (01)00884838099258(21)1348 1350 (01)00884838099258(21)1350 1367 (01)00884838099258(21)1367 1407 (01)00884838099258(21)1407 1181 (01)00884838099258(21)1181 1365 (01)00884838099258(21)1365 1503 (01)00884838099258(21)1503 455 (01)00884838099258(21)455 1489 (01)00884838099258(21)1489 1342 (01)00884838099258(21)1342 1666 (01)00884838099258(21)1666 1714 (01)00884838099258(21)1714 1673 (01)00884838099258(21)1673 1658 (01)00884838099258(21)1658 1733 (01)00884838099258(21)1733 1741 (01)00884838099258(21)1741 1173 (01)00884838099258(21)1173 1566 (01)00884838099258(21)1566 915 (01)00884838099258(21)915 1713 (01)00884838099258(21)1713 1688 (01)00884838099258(21)1688 936 (01)00884838099258(21)936 1602 (01)00884838099258(21)1602 1588 (01)00884838099258(21)1588 1193 (01)00884838099258(21)1193 1586 (01)00884838099258(21)1586 1665 (01)00884838099258(21)1665 1609 (01)00884838099258(21)1609 1463 (01)00884838099258(21)1463 969 (01)00884838099258(21)969 1280 (01)00884838099258(21)1280 1402 (01)00884838099258(21)1402 1598 (01)00884838099258(21)1598 1624 (01)00884838099258(21)1624 1537 (01)00884838099258(21)1537 1645 (01)00884838099258(21)1645 1355 (01)00884838099258(21)1355 1349 (01)00884838099258(21)1349 1736 (01)00884838099258(21)1736 1505 (01)00884838099258(21)1505 1664 (01)00884838099258(21)1664 1711 (01)00884838099258(21)1711 1862 (01)00884838099258(21)1862 1708 (01)00884838099258(21)1708 1447 (01)00884838099258(21)1447 1786 (01)00884838099258(21)1786 1428 (01)00884838099258(21)1428

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.