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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68528

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

Open FDA event record

Event summary

Timeline bucket
June 04, 2014
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

2 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 2

GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Z-1988-2014
Recall number
Z-1988-2014
Initiated
June 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3460

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

Code information

Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 00000030772HL8 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Distribution pattern

Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.

device · product 2 of 2

GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Z-1989-2014
Recall number
Z-1989-2014
Initiated
June 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
1053

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.

Code information

Mfg Lot or Serial # System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IQ1034RX01 00000000002998 IQ1039RX01 00000000002518 IQ1124RX01 00000000002435 IQ1128RX01 00000000002888 IQ1263RX01 00000000002944 IQ1300RX01 00000000002981 IQ1326RX01 00000000002855 IQ1346RX02 00000000002681 IQ1391RX01 FMITR170990989 IQ1001RX01 FMITR170990990 IQ1050RX02 FMITR170990991 IQ1053RX01 FMITR170990992 IQ1165RX01 FMITR170990993 IQ1261RX01 FMITR170990994 IQ1305RX01 FMITR170990995 IQ1316RX01 FMITR170990996 IQ1359RX01 FMITR170990066 IE1006RX08 FMITR170990139 IE1094RX01 FMITR170990846 IE6000RX01 FMITR170990987 IE1053RX02 00000000001140 IL1098RX01 00000000002571 IL1000RX04 FMITR170990297 IL1062XR05 FMITR170990988 IL1000XR03 00000000001Q21 A5145732 00000000001111 F5119123 00000000001180 A51043119 00000000002439 H5382007 FMITR170990137 A5105149 FMITR170990149 B5167310 FMITR170990165 B5119112 FMITR170990263 A5141714 FMITR170990264 D5249922 FMITR170990273 B5167311 FMITR170990291 C5343109 FMITR170990317 A5183761 FMITR170990923 A5102660 FMITR170990959 A5605736 FMITR170990960 A5605738 FMITR170990977 A5120523 FMITR170990983 A5303320 FMITR170990984 A5815416 00000000001054 XQ0026 00000000007298 XQ0035 00000000001913 XQ0066 00000000001108 XQ0018 00000000001103 XQ0023 00000000001060 XQ0028 00000000001422 XQ0036 00000000001814 XQ0052 00000000002299 XQ0057 00000000001096 XQ0027 00000000001406 XQ0056 00000000001104 XQ0059 00000000001197 XQ0065 00000000002461 XK0001 00000000002898 XK0002 00000000002600 XK0003 00000000002505 XQ0068 FMITR170990275 XQ0022 FMITR170990276 XQ0055 FMITR170990283 XQ0076 FMITR170990302 XQ0063 FMITR170990303 XQ0101 FMITR170990304 XQ0110 FMITR170990921 XK0005 FMITR170990922 XK0006 FMITR170990973 XK0007 00000000001954 0850070702 0000000000AG38 0850070714 00000000001870 0850070715 00000000002443 0850070726 00000000002875 0850070733 00000000002985 0850070734 00000000002665 0850070736 FMITR170990027 0850070704 FMITR170990028 0850070718 FMITR170990029 0850070730 FMITR170990030 0850070731 FMITR170990031 0850070735 FMITR170990032 0850070738 00000000002160 KW1006RX10 00000000001908 KW1006RX09 00000000002179 KW1007RX02 00000000002624 KW1077XR02 FMITR170990305 KW1001RX10 FMITR170990938 KW1018RX07 FMITR170990997 LV4000RX01 FMITR170990035 LB1050XR01 FMITR170990130 LB1050RX01 FMITR170990976 LB1076RX02 00000000002371 MT1014RX01 00000000002410 MT1014RX02 00000000002417 MT1014RX05 00000000002400 MT1014RX03 00000000002289 MT1014RX04 FMITR170990123 BMALTA03 FMITR170990124 BMALTA04 FMITR170990125 BMALTA07 FMITR170990300 BMALTA05 FMITR170990301 BMALTA06 00000000002606 RTD0984 FMITR170990164 TLB0207 00000000001196 NO1095RX03 00000000002073 RU2210RX01 00000000001062 SA1011RX04 00000000001412 SA1042RX07 00000000001762 SA1012RX13 00000000001694 SA1012RX14 00000000001419 SA1012RX15 00000000001143 SA1012RX06 00000000001747 SA1012RX12 00000000002740 SA1013RX01 00000000003036 SA1013RX02 00000000002974 SA1058RX09 00000000002563 SA1058RX05 00000000002650 SA1058RX11 00000000003021 SA2079RX04 00000000002958 SA2079RX05 00000000001390 SA2079RX02 00000000003080 SA2079RX03 FMITR170990017 SA1011RX06 FMITR170990034 SA1011RX03 FMITR170990133 SA1012RX08 FMITR170990159 SA1011RX07 FMITR170990166 SA1005RX07 FMITR170990269 SA1054RX04 FMITR170990270 SA1054RX06 FMITR170990272 SA1012RX17 FMITR170990292 SA1011RX05 FMITR170990319 SA1054RX02 FMITR170990962 SA1058RX08 FMITR170990963 SA1058RX06 FMITR170990964 SA1058RX03 FMITR170990965 SA1058RX04 FMITR170990966 SA1168RX05 FMITR170990967 SA1058RX10 FMITR170990843 SK1067RX02 00000000003196 SI4014RX02 00000000001765 DEL26417 00000000001564 DEL26418 00000000001782 DEL26419 00000000001705 UE277506 00000000004535 UE535A86 FMITR170990026 DEL26420 FMITR170990143 DE539242 FMITR170990282 GP005003 FMITR170990293 UPW25700 FMITR170990330 DP418841PH FMITR170990847 ME246209BE FMITR170990909 ME267403TO FMITR170990920 DE282017 FMITR170990924 ME504361 FMITR170990937 CEE15654 FMITR170990975 FPG86410 FMITR170990323 FA00RX01 FMITR170990998 O005RX17 FMITR170990974 387040XR08 00000000001018 0853070248 00000000001273 0853070260 00000000001764 0853070295 00000000002899 0853070321 FMITR170990119 0853070255 FMITR170990120 0853070271 FMITR170990121 0853070312 FMITR170990122 0853070314 FMITR170990329 60001RAD02 FMITR170990925 06004RAD05 FMITR170990939 06014RAD01 FMITR170990267 UG1025RX01 FMITR170990145 AE1026RX02 FMITR170990271 AE1104RX01 00000000001240 10433RAD01 00000000001242 10433RAD02 00000000001392 05262RAD01 00000000002545 IE1564RX02 FMITR170990142 00487RAD03 FMITR170990285 77069RAD02 FMITR170990045 388259146XRMET FMITR170990046 38864650XRMET FMITR170990047 38897737XRMET

Distribution pattern

Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.