Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86337

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

Open FDA event record

Event summary

Timeline bucket
August 14, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

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

8 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 8

NM/CT 850 Model Number: H3907AD

Z-2991-2020
Recall number
Z-2991-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 2 of 8

NM/CT 860, SPECT/CT

Z-2992-2020
Recall number
Z-2992-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 3 of 8

NM/CT 870 CZT Model # H3906CW

Z-2993-2020
Recall number
Z-2993-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 87CX63007 System ID: AH0101NM05 Serial # 87CX63008 System ID: 190020NU01 Serial # 87CX63006 System ID: 030240NU11 Serial # 87CX63015 System ID: 705743NM870 Serial # 87CX63014 System ID: 030078NU28 Serial # 87CX63011 System ID: M4184879 Serial # 87CX63003 System ID: M9886873 Serial # 87CX63004 System ID: X171582003 Serial # 87CX63009 System ID: M171582018 Serial # 87CX63010 System ID: UC1796NU01 Serial # 87CX63013 System ID: NO1068MN18 Serial # 87CX63005 System ID: A004NU20 Serial # 87CX63002 System ID: C028NU01 Serial # 87CX63012 System ID: C028NU02 Serial # 87CX63001 System ID: 900010NU12

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 4 of 8

Discovery NM 630 Model # H3101RH

Z-2994-2020
Recall number
Z-2994-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 63GX50024 System ID: 501450D630 Serial # 63GX50001 System ID: 863494NM Serial # 63GX50037 System ID: 3v05223D630A Serial # 63GX50060 System ID: 305223D630B Serial # 63GX50017 Not Available Serial # 63GX50034 System ID: 478289DIS Serial # 63GX50040 System ID: 0004624609 Serial # 63GX50014 System ID: 618998NM Serial # 63GX50019 System ID: 270745NM1 Serial # 63GX50016 System ID: Not Available Serial # 63GX50022 System ID: 906225CARDNM1 Serial # 63GX50021 System ID: 906225CARDNM2 Serial # 63GX50018 System ID: 269637NM630 Serial # 63GX50009 System ID: NM555658 Serial # 63GX50031 System ID: Not Available Serial # 63GX50020 System ID: 402481D630C Serial # 63GX50054 System ID: 973450D630 Serial # 63GX50008 System ID: 856641NM Serial # 63GX50061 System ID: 702962NM1 Serial # 63GX50062 System ID: 702724NM1 Serial # 63GX50050 System ID: 702388DISC Serial # 63GX50043 Not Available Serial # 63GX50032 System ID: 513861NM Serial # 63GX50055 System ID: 513861NM1 Serial # 63GX50013 System ID: 740MGD630 Serial # 63GX50047 System ID: 440743D630 Serial # 63GX50002 System ID: 419251NM Serial # 63GX50025 System ID: 330841DISCNM Serial # 63GX50033 System ID: 330841DISCNM2 Serial # 63GX50038 System ID: 918756D630 Serial # 63GX50044 System ID: 803865D630 Serial # 63GX50035 Not Available Serial # 63GX50005 System ID: 713440NM630B Serial # 63GX50029 System ID: 281MHNE630 Serial # 63GX50012 System ID: 832505D630 Serial # 63GX50046 System ID: 210351NM Serial # 63GX50039 System ID: 281MWL630A Serial # 63GX50049 System ID: 281MWL630B Serial # 63GX50011 System ID: LGMONT630 Serial # 63GX50030 System ID: 434243DIS Serial # 63GX50052 System ID: NM5892AR Serial # 63GX50051 System ID: NM2009AR Serial # 63GX50015 System ID: NM63GX50015 Serial # 63GX50027 System ID: NM63GX50027 Serial # 63GX50036 System ID: NM63GX50036 Serial # 63GX50006 System ID: NM63GX50006 Serial # 63GX50007 System ID: NM63GX50007 Serial # 63GX50010 System ID: NM63GX50010 Serial # 63GX50026 System ID: NM63GX50026XE Serial # 63GX50057 System ID: 082426190035 Serial # 63GX50045 System ID: 082426090053 Serial # 63GX50023 System ID: 403438NU01 Serial # 63GX50048 System ID: 418404NU02 Serial # 63GX50041 System ID: 083026202460918 Serial # 63GX50003 System ID: 083026860786218 Serial # 63GX50028 System ID: 083026806403618 Serial # 63GX50058 System ID: 083026803079619 Serial # 63GX50042 System ID: 0853260185 Serial # 63GX50053 System ID: 1573MI0011 Serial # 63GX50004 System ID: 06184NUC05 Serial # 63GX50056 System ID: 5973MI0019 Serial # 63GX50059 System ID: 5973MI0018

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 5 of 8

NM 830 Model # H3910AC

Z-2995-2020
Recall number
Z-2995-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID: 225761NM Serial # 830X60016 System ID: 225761NM Serial # 830X60019 System ID: 573458NM Serial # 830X60023 System ID: 718238D830 Serial # 830X60006 System ID: 716862NM830 Serial # 830X60015 System ID: 585396NM Serial # 830X60003 System ID: 585786NM830 Serial # 830X60025 System ID: 405717NM830 Serial # 830X60021 System ID: 615316NM830 Serial # 830X60017 System ID: 956323NM830 Serial # 830X60002 System ID: 100039NU05 Serial # 830X60022 System ID: 705743DNM830 Serial # 830X60024 System ID: 416898NM830 Serial # 830X60013 System ID: M4040557 Serial # 830X60010 System ID: NS0102 Serial # 830X60020 System ID: NS0101 Serial # 830X60009 System ID: 0850260168 Serial # 830X60005 System ID: 0850260165 Serial # 830X60008 System ID: 0850260166 Serial # 830X60007 System ID: 752030NU01

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 6 of 8

Discovery 670 DR Model # H3100BT

Z-2996-2020
Recall number
Z-2996-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # DRGX56002 System ID: 4445804NM11 Serial # DRGX56005 System ID: 614CVA6702CT Serial # DRGX56004 System ID: 403343D670A Serial # DRGX56017 System ID: 110002NU06 Serial # DRGX56018 System ID: X7410502 Serial # DRGX56003 System ID: 403438NU02 Serial # DRGX56010 System ID: UC4097NU02 Serial # DRGX56008 System ID: 826251NU01 Serial # DRGX56007 System ID: H2101NUC35 Serial # DRGX56006 System ID: 083026063363718 Serial # DRGX56011 System ID: 083026281900218 Serial # DRGX56009 System ID: 083049206531619 Serial # DRGX56021 System ID: 083026603411518 Serial # DRGX56019 System ID: A220806209 Serial # DRGX56012 System ID: STD01300 Serial # DRGX56014 Not Available Serial # DRGX56016 System ID: GEE34069 Serial # DRGX56020 System ID: DEL26498 Serial # DRGX56022 System ID: DE6588153 Serial # DRGX56015 System ID: 0853260202

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 7 of 8

Discovery NM670 Pro Model # H3100XB

Z-2997-2020
Recall number
Z-2997-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # PRGX52001 System ID: NMPRGX52001 Serial # PRGX52003 System ID: 082426210033 Serial # PRGX52008 System ID: 082426120037 Serial # PRGX52005 System ID: 082426120039 Serial # PRGX52007 System ID: 082426290010 Serial # PRGX52004 System ID: 082426180017 Serial # PRGX52009 System ID: 082426130053 Serial # PRGX52002 System ID:082426150044 Serial # PRGX52006 System ID:082426160065

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

device · product 8 of 8

NM/CT 870 DR Model # H3100AS

Z-2998-2020
Recall number
Z-2998-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rotor bearing screws were found loose on detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rotor bearing screws were found loose on detector.

Code information

Serial # 870X64001 System ID: 030020NU06 Serial # 870X64004 System ID: M4018555 Serial # 870X64012 System ID: X634445001 Serial # 870X64007 System ID: V2728113 Serial # 870X64009 System ID: M4016255 Serial # 870X64026 System ID: M40230109 Serial # 870X64017 System ID: M40240121 Serial # 870X64018 System ID:M40240121 Serial # 870X64015 System ID:M40345223 Serial # 870X64016 System ID:499221NU01 Serial # 870X64031 System ID:083049209623319 Serial # 870X64014 System ID:IL1028NM41 Serial # 870X64022 System ID: A5173220 Serial # 870X64019 System ID: 0850260167XE6 Serial # 870X64020 System ID: 0850260169 Serial # 870X64025 System ID: EMM0135 Serial # 870X64010 System ID:NM2882PA Serial # 870X64027 System ID: PL0398NM01 Serial # 870X64029 System ID: PL1031NM01 Serial # 870X64030 System ID: PL2190NM01 Serial # 870X64028 System ID: PL0372NM01 Serial # 870X64023 System ID: 600042NM10 Serial # 870X64013 System ID: NP473631 Serial # 870X64021 System ID: G001NU12 Serial # 870X64008 System ID:00669NUC03

Distribution pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM