Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97643

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

Open FDA event record

Event summary

Timeline bucket
September 05, 2025
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Philips Ultrasound, Inc

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

11 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 11

Philips 3D6-2 Ultrasound Transducer

Z-1618-2026
Recall number
Z-1618-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.

Distribution pattern

US Nationwide distribution.

device · product 2 of 11

Philips C9-4 Ultrasound Transducer

Z-1619-2026
Recall number
Z-1619-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605365021; UDI: N/A; Serial No. 033DZ4.

Distribution pattern

US Nationwide distribution.

device · product 3 of 11

Philips L12-5 Ultrasound Transducer

Z-1620-2026
Recall number
Z-1620-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB.

Distribution pattern

US Nationwide distribution.

device · product 4 of 11

Philips L17-5 Ultrasound Transducer

Z-1621-2026
Recall number
Z-1621-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605366371, 989605388061; UDI: N/A; Serial No. 03228X, 03360Q.

Distribution pattern

US Nationwide distribution.

device · product 5 of 11

Philips Mini Multi TEE Ultrasound Transducer

Z-1622-2026
Recall number
Z-1622-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.

Distribution pattern

US Nationwide distribution.

device · product 6 of 11

Philips OMNI II TEE Ultrasound Transducer

Z-1623-2026
Recall number
Z-1623-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.

Distribution pattern

US Nationwide distribution.

device · product 7 of 11

Philips OMNI III TEE Ultrasound Transducer

Z-1624-2026
Recall number
Z-1624-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0, (01)00884838067585(21)039Q2L, (01)00884838067585(21)02YCFD, (01)00884838067585(21)B05DX2, (01)00884838067585(21)02WCTB, (01)00884838067585(21)039PC3, (01)00884838067585(21)035V3H, (01)00884838067585(21)038DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)02CGWH, (01)00884838067585(21)032MLN, (01)00884838067585(21)038LT2, (01)00884838067585(21)03G4GG, (01)00884838067585(21)03435X, (01)00884838067585(21)032MMK, (01)00884838067585(21)B0JFDK, (01)00884838067585(21)02WMD4, (01)00884838067585(21)02JP4Z, (01)00884838067585(21)031LCH, (01)00884838067585(21)02JJ6T, (01)00884838067585(21)039JWV, (01)00884838067585(21)035YQG, (01)00884838067585(21)03C04R, (01)00884838067585(21)02DCH7, (01)00884838067585(21)02D9TH, (01)00884838067585(21)035Q9M, (01)00884838067585(21)031CDK, (01)00884838067585(21)0379BH; Serial No. 02ZTTT, 02DFBP, B0X7MD, 039MMD, 02VWNV, 02JQPG, 02PCMT, 0341PG, 02GR5B, 035PWZ, 02QLMQ, B0JFCN, 03CVTB, 03C009, 02Y7HM, 02VTGK, 037CHG, 03G0BB, 02WH6F, 02QK2L, 038MJ6, 037F68, 038GL7, 0344C9, 037HLM, 035R8K, 02JL01, 02JJ0T, 031LC8, 039JWQ, 035PYK, 03436F, 039PCB, 031HN7, 02P8GV, 039HQ2, B07FFB, 03F770, 035Q9P, 0319LX, 02DG0D, B0JF93, 03C7Q0, 039Q2L, 02YCFD, B05DX2, 02WCTB, 039PC3, 035V3H, 038DX2, B0LYR8, 02CGWH, 032MLN, 035P8R, 038LT2, 03G4GG, 03435X, 032MMK, 02QGKV, B0JFDK, 02VN40, 032FKW, 02WMD4, 02JP4Z, 031LCH, 02JJ6T, 039JWV, 035YQG, 03C04R, 03C6ZH, 02DCH7, 02D9TH, 035Q9M, 031CDK, 0379BH.

Distribution pattern

US Nationwide distribution.

device · product 8 of 11

Philips S4-1 Ultrasound Transducer

Z-1625-2026
Recall number
Z-1625-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605458221, 989605458222, 989605477101; UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK, (01)00884838085183(21)B25VX0, (01)00884838085183(21)B21Y07, (01)00884838085183(21)B21Y6L, (01)00884838085183(21)B21XYW, (01)00884838085183(21)B1RCNL, (01)00884838074231(21)B21Y64, (01)00884838074231(21)B21YF6, (01)00884838085183(21)B2D34Z, (01)00884838085183(21)B1RCVN, (01)00884838085183(21)B1W8DH, (01)00884838085183(21)B21XTP, (01)00884838085183(21)B21XXQ, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.

Distribution pattern

US Nationwide distribution.

device · product 9 of 11

Philips S5-2 Ultrasound Transducer

Z-1626-2026
Recall number
Z-1626-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.

Distribution pattern

US Nationwide distribution.

device · product 10 of 11

Philips X3-1 Ultrasound Transducer

Z-1627-2026
Recall number
Z-1627-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.

Distribution pattern

US Nationwide distribution.

device · product 11 of 11

Philips X7-2 Ultrasound Transducer

Z-1628-2026
Recall number
Z-1628-2026
Initiated
September 05, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Philips Ultrasound, Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Code information

Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.

Distribution pattern

US Nationwide distribution.