FDA Device recall Z-1078-2013

GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

FDA Device
Class II
terminated
Published 2013-04-17

On 2013-04-17 the FDA classified a Class II recall of GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera by Ge Healthcare, citing accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may i….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1078-2013
Classification	Class II
Status	terminated
Initiated	2012-03-06
Published	2013-04-17
Last updated	2026-09-13 11:53 UTC
Company	Ge Healthcare
Distribution	US

Product

GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.

Reason

Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.

Identifiers

code_info	System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK118… System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 7

code_info

System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK118…

System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 7

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.