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.
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 12
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781196; UDI-DI N/A. b. Model No. 781343; UDI-DI 00884838055292. c. Model No. 781296; UDI-DI 00884838004108. All units are affected.
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 2 of 12
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781346; UDI-DI 00884838068469. b. Model No. 781283; UDI-DI 00884838009806. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 3 of 12
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781277; UDI-DI N/A. b. Model No. 781177; UDI-DI N/A. c. Model No. 781278; UDI-DI 00884838004139. d. Model No. 781344; UDI-DI N/A. e. Model No. 781345; UDI-DI N/A. All units affected
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781153; UDI-DI N/A. b. Model No. 781253; UDI-DI N/A. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 6 of 12
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781262; UDI-DI 00884838068445. b. Model No. 781261; UDI-DI 00884838068438. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 7 of 12
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781271; UDI-DI 00884838068452. b. Model No. 782105; UDI-DI 00884838098312. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 8 of 12
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
Model No. 781172; .UDI-DI N/A All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 9 of 12
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
Model No. 781173; UDI-DI N/A. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 10 of 12
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
Model No. 781171; UDI-DI N/A. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 11 of 12
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781260; UDI-DI 00884838095076. b. Model No. 782112; UDI-DI 00884838098886. All units affected
Distribution pattern
Worldwide - US Nationwide distribution.
device · product 12 of 12
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
These labels are deterministic app interpretations, not FDA categories.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Code information
a. Model No. 781270; UDI-DI 00884838095083. b. Model No. 782113; UDI-DI 00884838098909. c. Model No. 782129; UDI-DI 00884838105805. All units affected
